FDA 510(k) Application Details - K984388

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K984388
Device Name Dressing, Wound, Collagen
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
100 HEADQUARTERS PARK DR.
SKILLMAN, NJ 08558 US
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Contact ADRIIENNE MCNALLY
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 12/08/1998
Decision Date 03/03/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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