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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 K935848
Device Name BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING
Applicant
Brady Medical Products Co.
727 W. Glendale Ave.
P.O. Box 571
Milwaukee,  WI  53201
Applicant Contact TERRI TESSMANN
Correspondent
Brady Medical Products Co.
727 W. Glendale Ave.
P.O. Box 571
Milwaukee,  WI  53201
Correspondent Contact TERRI TESSMANN
Regulation Number878.4022
Classification Product Code
NAE  
Date Received12/08/1993
Decision Date 02/15/1994
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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