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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 K941216
Device Name HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING
Applicant
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Applicant Contact PRICILLA WHITEHEAD
Correspondent
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Correspondent Contact PRICILLA WHITEHEAD
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/14/1994
Decision Date 05/20/1994
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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