FDA 510(k) Application Details - K760516

Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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510(K) Number K760516
Device Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

, US
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Regulation Number 870.3470

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Classification Product Code DXZ
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Date Received 08/25/1976
Decision Date 01/05/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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