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Guidance for Third Parties and FDA Staff - Third Party Review of Premarket Notifications: Appendix 5: Standards Data Form for Abbreviated 510(k)s

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(Standards Data Sheet)

510(k) Number:                 

 

Standard Organization No:                 
or
Standard Identification No:
                 
or
CDRH Internal Reference No:
                 

 

 

Declaration of Conformity Elements:

Any Adaptations Appliedyes    no    
Any Requirements Not Applicableyes no 
Any Deviations Appliedyes no 
Any Differences in Device Tested and Finished Productyes no 
*Is There a Third Party or Test Lab Involvedyes no 

 

Was there another standard used in the review of this submission?yes    no    

If another standard was used, please fill out an additional form.

* This is not the third party that reviews 510ks
 

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