FDA 510(k) Application Details - K990086

Device Classification Name Dressing, Wound, Drug

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510(K) Number K990086
Device Name Dressing, Wound, Drug
Applicant INTEGRA LIFESCIENCES CORP.
105 MORGAN LANE
PLAINSBORO, NJ 08536 US
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Contact JUDITH E O'GRADY
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 01/11/1999
Decision Date 03/31/1999
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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