FDA 510(k) Application Details - K072113

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K072113
Device Name Dressing, Wound, Collagen
Applicant INTEGRA LIFESCIENCES CORP.
311C ENTERPRISE DRIVE
PLAINSBORO, NJ 08536 US
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Contact DIANA M BORDON
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 08/01/2007
Decision Date 10/10/2007
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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