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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, Hydrogel Without Drug And/Or Biologic
510(k) Number K922666
Device Name TRANSORB(TM) ULCER & WOUND DRESSING
Applicant
Brady Medical Products Co.
727 W. Glendale Ave.
P.O. Box 571
Milwaukee,  WI  53201
Applicant Contact W. K REAMS
Correspondent
Brady Medical Products Co.
727 W. Glendale Ave.
P.O. Box 571
Milwaukee,  WI  53201
Correspondent Contact W. K REAMS
Regulation Number878.4022
Classification Product Code
NAE  
Date Received05/28/1992
Decision Date 11/23/1992
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
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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