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U.S. Department of Health and Human Services

Medical Devices

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Standards Data Form for Abbreviated 510(k)s

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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