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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k122752
B. Purpose for Submission:
New device and addition of new analyte
C. Measured:
Propoxyphene
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What is purpose for submission?
The purpose for submission is to provide a clear indication of the reason or intent behind submitting a document or information.
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Anyone who is submitting a document or information may be required to provide a purpose for submission.
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The purpose of providing a purpose for submission is to ensure transparency and clarity in communication regarding the submission of documents or information.
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The information to be reported on a purpose for submission may vary, but typically it includes the reason for submitting, the relevance of the submission, and any specific requirements or instructions.
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