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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K964231
Device Name NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
Applicant
NORTH AMERICAN STERILIZATION & PACKAGING CO.
18 WHITE LAKE RD.
SPARTA,  NJ  07871
Applicant Contact CHARLES E MEISCH
Correspondent
NORTH AMERICAN STERILIZATION & PACKAGING CO.
18 WHITE LAKE RD.
SPARTA,  NJ  07871
Correspondent Contact CHARLES E MEISCH
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/23/1996
Decision Date 03/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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