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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 K944333
Device Name HYDRODERM GEL WOUND DRESSING
Applicant
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Applicant Contact PRISCILLA WHTEHEAD
Correspondent
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Correspondent Contact PRISCILLA WHTEHEAD
Classification Product Code
MGQ  
Date Received09/06/1994
Decision Date 11/10/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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