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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, Drug
510(k) Number K940076
Device Name DERMASSIST WET DRESSING, WATER
Applicant
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Applicant Contact PRISCILLA WHITEHEAD
Correspondent
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Correspondent Contact PRISCILLA WHITEHEAD
Classification Product Code
FRO  
Date Received01/06/1994
Decision Date 03/03/1994
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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