FDA 510(k) Application Details - K982597

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K982597
Device Name Dressing, Wound, Collagen
Applicant JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON, TX 76004-0130 US
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Contact TERRY J DAGNON
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 07/24/1998
Decision Date 08/20/1998
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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