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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 K946030
Device Name DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING
Applicant
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Applicant Contact ERIC LUO
Correspondent
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Correspondent Contact ERIC LUO
Classification Product Code
MGQ  
Date Received12/09/1994
Decision Date 02/27/1995
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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