FDA 510(k) Application Details - K760995

Device Classification Name Tray, Declotting (Including Contents)

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510(K) Number K760995
Device Name Tray, Declotting (Including Contents)
Applicant DRAVON MEDICAL, INC.

, US
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Regulation Number 876.5820

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Classification Product Code FJZ
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Date Received 11/08/1976
Decision Date 01/06/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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