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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 K921502
Device Name HYSORB WOUND DRESSING
Applicant
KINGSTON TECHNOLOGIES, INC.
2235 ROUTE 130
DAYTON,  NJ  08810
Applicant Contact KENNETH BLASHKA
Correspondent
KINGSTON TECHNOLOGIES, INC.
2235 ROUTE 130
DAYTON,  NJ  08810
Correspondent Contact KENNETH BLASHKA
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/31/1992
Decision Date 09/29/1992
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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