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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K940814
Device Name HYDRO-M(TM) WOUND GEL
Applicant
Kingston Technologies, Inc.
2235 Rte. 130
Dayton,  NJ  08810
Applicant Contact KEN BLASHKA
Correspondent
Kingston Technologies, Inc.
2235 Rte. 130
Dayton,  NJ  08810
Correspondent Contact KEN BLASHKA
Classification Product Code
MGQ  
Date Received02/22/1994
Decision Date 05/12/1994
Decision Substantially Equivalent (SESE)
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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