FDA 510(k) Application Details - K962352

Device Classification Name Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic

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510(K) Number K962352
Device Name Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic
Applicant NORTH AMERICAN STERILIZATION & PACKAGING CO.
18 WHITE LAKE RD.
P.O. BOX 558
SPARTA, NJ 07871 US
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Contact CHARLES E MEISCH
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Regulation Number 878.4022

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Classification Product Code NAE
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Date Received 06/18/1996
Decision Date 08/02/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K962352


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