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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, Hydrophilic
510(k) Number K914575
Device Name SORBSAN TOPICAL WOUND DRESSING (MODIFIED)
Applicant
Dow B. Hickam, Inc.
P.O. Box 2006
Sugarland,  TX  77487
Applicant Contact ROBIN F SCAMUFFA
Correspondent
Dow B. Hickam, Inc.
P.O. Box 2006
Sugarland,  TX  77487
Correspondent Contact ROBIN F SCAMUFFA
Regulation Number878.4018
Classification Product Code
NAC  
Date Received10/15/1991
Decision Date 12/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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