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FDA > CDRH > Device Advice > 510(k) Submission Process > 510(k) Cover Sheet Memorandum

PDF Printer Version510(k) Cover Sheet Memorandum

Food and Drug Administration
Office of Device Evaluation &
Office of In Vitro Diagnostics


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- Final Decision (SE, SE with Limitations, NSE, Withdrawn, etc.).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.):

YES

NO

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:__________________________________________________________

Review:____________________________________________________________________________

(Branch Chief)
(Branch Code)
(Date)

Final Review:______________________________________________________________________

(Division Director)
(Date)

Updated July 30, 2007

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