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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, electrosurgical
510(k) Number K871435
Device Name BARD EMS SYSTEM 6000 E.S.U.
Applicant
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Applicant Contact CATHERINE V BEATH
Correspondent
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Correspondent Contact CATHERINE V BEATH
Regulation Number878.4400
Classification Product Code
HAM  
Date Received04/13/1987
Decision Date 05/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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