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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 K954230
Device Name SORBSAN PLUS TOPICAL WOUND DRESSING
Applicant
Dow Hickam Pharmaceuticals, Inc.
10410 Corporate Dr.
Sugar Land,  TX  77478
Applicant Contact BARBARA T SMITH
Correspondent
Dow Hickam Pharmaceuticals, Inc.
10410 Corporate Dr.
Sugar Land,  TX  77478
Correspondent Contact BARBARA T SMITH
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/11/1995
Decision Date 11/08/1995
Decision Substantially Equivalent (SESE)
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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