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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K972703
Device Name REDYROB-CLOSED WOUND DRAINAGE SYSTEM
Applicant
B. Braun Medical, Inc.
824 12th Ave.
Bethlehem,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B. Braun Medical, Inc.
824 12th Ave.
Bethlehem,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number878.4680
Classification Product Code
GCY  
Date Received07/18/1997
Decision Date 10/01/1997
Decision Substantially Equivalent (SESE)
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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