FDA 510(k) Application Details - K980382

Device Classification Name Bandage, Liquid

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510(K) Number K980382
Device Name Bandage, Liquid
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
100 HEADQUARTERS PARK DR.
SKILLMAN, NJ 08558 US
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Contact ADRIENNE MCNALLY
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 02/02/1998
Decision Date 03/09/1998
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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