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March 2, 2018,
Shenzhen Brad Electronic Technologies Co., Ltd.
Ennui CIA
QA Manager
4/F, Block 11, Tongue Industrial District
Lezhujiao, Hangman Community, Mixing, Began
Shenzhen, Guangdong, 518102
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Open the 002510k summarydocx file using a compatible document editor.
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Begin by entering the title of the document, which should clearly identify the purpose of the summary.
04
Fill in the section that requires the submitter's contact information, including name, address, phone number, and email.
05
Provide the required FDA premarket submission number in the designated field.
06
Indicate the type of submission by selecting the appropriate option from the provided choices.
07
If applicable, mention the FDA product code that corresponds to the device under review.
08
Include a concise summary of the technological characteristics of the device.
09
Describe the intended use and indications for use of the device.
10
File the appropriate decision summary in the provided section.
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In the final section, provide any additional comments or pertinent information that pertains to the submission.
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Who needs 002510k summarydocx?
01
The 002510k summarydocx form is required by medical device manufacturers or submitters who are seeking clearance or approval from the U.S. Food and Drug Administration (FDA) for market distribution of their device. This summary document is an essential component of the FDA's premarket submission process, specifically for 510(k) submissions.
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What is 002510k summarydocx?
002510k summarydocx is a summary document required by the FDA for medical device manufacturers.
Who is required to file 002510k summarydocx?
Medical device manufacturers are required to file 002510k summarydocx.
How to fill out 002510k summarydocx?
002510k summarydocx must be filled out with detailed information about the medical device being submitted for FDA approval.
What is the purpose of 002510k summarydocx?
The purpose of 002510k summarydocx is to provide the FDA with a summary of the safety and effectiveness of the medical device.
What information must be reported on 002510k summarydocx?
Information such as device description, indications for use, and technological characteristics must be reported on 002510k summarydocx.
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