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Fda.gzov/AboutFDA/CentersOtfices/CDRH/CDRHOffices/ucmn II 5809. htm for the Center for Devices and Radiological Health s CDRH- s Office of Compliance. OOD Center Thickness 0. 08mm Base Curve Varies with Power 8. 2 mm to 9. 2 mm Power -20. 00D to 20. OOD -6. 5925 Product Code LPL 21 CFR 886. 5925 Product Code MVN Page 1 6/10/2014 Aj J 6 Legally Marketed Equivalent Device Biomedics 55 ocufilcon D Predicate Device Name CooperVision Inc. Manufacturer 5 10O k Number K091339 LPL MVN 7 Device...
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01
First, gather all necessary information and documentation related to the k141280 510k summary.
02
Start by providing a clear and concise summary of the intended use of the medical device.
03
Include a detailed description of the device, its components, and any accessories.
04
Outline the device's design, manufacturing process, and labeling.
05
Describe any performance testing or clinical evaluation conducted on the device.
06
Include a list of any applicable standards or regulations that the device complies with.
07
Provide information on any potential risks or hazards associated with the device.
08
Include a summary of any existing data or studies supporting the safety and effectiveness of the device.
09
Finally, review the completed k141280 510k summary for accuracy and completeness before submission.
Who needs k141280 510k summary?
01
Medical device manufacturers who intend to submit a k141280 510k application for their device.
02
Regulatory affairs professionals who are involved in preparing and submitting 510k summaries.
03
Health authorities and regulatory bodies who review and evaluate 510k submissions.
04
Healthcare professionals and clinicians who need to understand the safety and effectiveness of a medical device.
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Patients and consumers who want to make informed decisions about using a specific medical device.
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What is k141280 510k summary?
The k141280 510k summary is a summary of the safety and effectiveness data for a medical device that is being submitted for FDA clearance.
Who is required to file k141280 510k summary?
Manufacturers of medical devices are required to file a 510k summary for their device.
How to fill out k141280 510k summary?
The k141280 510k summary should be filled out with detailed information about the device, its intended use, the testing conducted, and the results.
What is the purpose of k141280 510k summary?
The purpose of the k141280 510k summary is to demonstrate to the FDA that the device is safe and effective for its intended use.
What information must be reported on k141280 510k summary?
The k141280 510k summary must include information on the device design, materials, labeling, and any clinical testing that has been conducted.
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