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FDA 510(k) Application Details - K964231
Device Classification Name
Bandage, Liquid
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510(K) Number
K964231
Device Name
Bandage, Liquid
Applicant
NORTH AMERICAN STERILIZATION & PACKAGING CO.
18 WHITE LAKE RD.
SPARTA, NJ 07871 US
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Contact
CHARLES E MEISCH
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Regulation Number
880.5090
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Classification Product Code
KMF
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More FDA Info for this Product Code
Date Received
10/23/1996
Decision Date
03/10/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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