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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 K942815
Device Name HYDROSKIN WOUND DRESSING
Applicant
Hymedix Intl., Inc.
2235 Rte. 130
Dayton,  NJ  08810
Applicant Contact KEN BLASHKA
Correspondent
Hymedix Intl., Inc.
2235 Rte. 130
Dayton,  NJ  08810
Correspondent Contact KEN BLASHKA
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/15/1994
Decision Date 07/11/1994
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
Predetermined Change
Control Plan Authorized		 No
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