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U.S. Department of Health and Human Services

Medical Devices

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510(k) Cover Sheet Memorandum




From: Reviewer Name ______________________________________________

Subject: 510(k) Number ______________________________________________

To: The Record

Please list CTS decision code _____________

- Refused to accept (Note: this is considered the first review cycle, See Screening Checklist
- Hold (Additional Information or Telephone Hold).
- Final Decision (SE, SE with Limitations, NSE, Withdrawn, etc.).

Please complete the following for a final clearance decision (i.e., SE, SE with Limitations, etc.):



Indications for Use Page Attach IFU



510(k) Summary /510(k) Statement Attach Summary



Truthful and Accurate Statement. Must be present for a Final Decision



Is the device Class III?

If yes, does firm include Class III Summary?


Must be present for a Final Decision



Does firm reference standards?
(If yes, please Abbreviated Standards Data Form



Is this a combination product?
(Please specify category ,



Is this a reprocessed single use device?

(Guidance for Industry and FDA Staff – MDUFMA - Validation Data in 510(k)s for Reprocessed Single-Use Medical Devices )



Is this device intended for pediatric use only?



Is this a prescription device? (If both prescription & OTC, check both boxes.)



Is clinical data necessary to support the review of this 510(k)?



Does this device include an Animal Tissue Source?



Is this device subject to Section 522 Postmarket Surveillance?
(Postmarket Surveillance Guidance)
Contact OSB.



Is this device subject to the Tracking Regulation? (Medical Device Tracking Guidance) Contact OC.




Regulation Number Class* Product Code

(*If unclassified, see 510(k) Staff)

Additional Product Codes:__________________________________________________________


(Branch Chief)
(Branch Code)

Final Review:______________________________________________________________________

(Division Director)