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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 Applied yes      no     
Any Requirements Not Applicable yes   no  
Any Deviations Applied yes   no  
Any Differences in Device Tested and Finished Product yes   no  
*Is There a Third Party or Test Lab Involved yes   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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