Get the free 21 CFR 807.93 - Content and format of a 510(k) statement.
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)c(th1 4APR8 201if Lori Technologies Corporation 51 0(k) Notification 510)(k) SubmissionXEOROTUPTRADITIONAL Submission Date: 01/10111artificial saliva510(k) Summary Submitted by Owner's Name Address
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How to fill out 21 cfr 80793
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01
To fill out 21 CFR 80793, follow the steps below:
02
Begin by including the applicant's name, complete address, and contact information.
03
Provide the FDA-assigned registration number, if applicable.
04
Indicate the specific regulation section or subpart that is being modified, supplemented, or waived.
05
Clearly state the reason for the modification, supplement, or waiver request.
06
Include any supporting documentation or evidence to justify the request.
07
Specify any proposed changes or additions to the regulation.
08
Sign and date the form, indicating the authorized representative of the applicant.
09
Submit the completed form along with any required fees and supporting documents to the FDA.
10
Keep a copy of the filled-out form for your records.
Who needs 21 cfr 80793?
01
21 CFR 80793 is required for individuals or organizations who need to request a modification, supplement, or waiver of a specific regulation or subpart in regards to FDA regulations.
02
This may include medical device manufacturers, distributors, importers, or any other stakeholders who are seeking to make changes to existing regulations.
03
It is important to consult the specific FDA regulations and guidelines to determine if 21 CFR 80793 is applicable to your situation.
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What is 21 cfr 80793?
21 CFR 807.93 is a regulation that requires medical device manufacturers to submit reports on corrections and removals of devices.
Who is required to file 21 cfr 80793?
All medical device manufacturers are required to file 21 CFR 807.93.
How to fill out 21 cfr 80793?
To fill out 21 CFR 807.93, manufacturers must include information on corrections and removals of devices in a timely manner.
What is the purpose of 21 cfr 80793?
The purpose of 21 CFR 807.93 is to ensure that corrections and removals of medical devices are reported and addressed promptly.
What information must be reported on 21 cfr 80793?
Manufacturers must report information on corrections and removals of devices, including the reason for the action and the number of affected units.
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