FDA 510(k) Application Details - K973688

Device Classification Name Dressing, Wound, Drug

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510(K) Number K973688
Device Name Dressing, Wound, Drug
Applicant CONVATEC LTD.
100 HEADQUARTERS PARK DR.
SKILLMAN, NJ 08558 US
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Contact ANDRIENNE MCNALLY
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 09/26/1997
Decision Date 12/23/1997
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K973688


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