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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 K940738
Device Name KTI HY-Q(TM) WOUND DRESSING
Applicant
KINGSTON TECHNOLOGIES, INC.
2235-B ROUTE 130
DAYTON,  NJ  08810
Applicant Contact KEN BLASHKA
Correspondent
KINGSTON TECHNOLOGIES, INC.
2235-B ROUTE 130
DAYTON,  NJ  08810
Correspondent Contact KEN BLASHKA
Regulation Number880.5090
Classification Product Code
KMF  
Date Received02/17/1994
Decision Date 05/06/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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