Get the free osferion 510k no k080065 may 2 2008 summary - accessdata fda

Stacy Abbatiello Kluesner RAC Re K081561 Trade/Device Name OSferion D Dated June 2 2008 Received June 13 2008 Dear Ms. The OSferion D product range consists of two product types with porosities of 75 and 60 and of three granule sizes G0 0. OLYMPUS 510 k SUMMARY JUL 28 2008 OSferion D May 30 2008 1 General Information Owner/Operator OLYMPUS TERUMO BIOMATERIALS CORP. K080065 ORTHOVITA INC. K032409 Device Description OSferion D is a white porous mat...

How to fill out osferion 510k no k080065

How to fill out osferion 510k no k080065?

1. Start by carefully reading the instructions and requirements outlined in the osferion 510k form.
2. Gather all the necessary information and documentation required for the application process. This may include details about the device, its intended use, any previous approvals or clearances, testing data, and any other relevant information.
3. Fill out the form accurately and completely. Provide all the requested information, ensuring that it is legible and organized. Use black ink and follow any specific formatting guidelines specified in the form.
4. Double-check all the filled-out sections to ensure they are error-free. Mistakes or omissions can delay the approval process or result in a rejection.
5. Attach any required supporting documents or additional information to the application. Make sure to include all relevant documentation to support the safety and effectiveness of the device.
6. Review the completed application to verify that all sections are filled out correctly and that all necessary attachments are included.
7. Submit the completed application and supporting documents to the designated authority or regulatory body. Follow any specific submission procedures outlined in the instructions.
8. Keep a copy of the complete application for your records. This will serve as a reference and may be required for future inquiries or audits.

Who needs osferion 510k no k080065?

1. Manufacturers or distributors of medical devices that are substantially equivalent to an already cleared device need osferion 510k no k080065. This process is necessary to gain market clearance from the relevant regulatory body.
2. Companies seeking to introduce a new device or make modifications to an existing device may also require osferion 510k no k080065. This submission helps demonstrate that the device is safe and effective for its intended use.
3. Medical professionals, consultants, or individuals involved in regulatory affairs may also need to familiarize themselves with osferion 510k no k080065 to better understand the requirements and processes involved in gaining market clearance for medical devices.

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What is osferion 510k no k080065?

Osferion 510k no k080065 is a premarket notification submitted to the FDA for a medical device.

Who is required to file osferion 510k no k080065?

The manufacturer or distributor of the medical device is required to file the osferion 510k no k080065.

How to fill out osferion 510k no k080065?

The osferion 510k no k080065 must be filled out according to the FDA guidelines and regulations for premarket notifications of medical devices.

What is the purpose of osferion 510k no k080065?

The purpose of osferion 510k no k080065 is to demonstrate that the device is substantially equivalent to a device that is already legally marketed.

What information must be reported on osferion 510k no k080065?

The osferion 510k no k080065 must include information about the device, its intended use, design, materials, performance, and labeling.