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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K940816
Device Name BARD(R) EXPANDED PTFE VASCULAR GRAFT
Applicant
C.R. Bard, Inc.
169 New Boston St.
Woburn,  MA 
Applicant Contact RAYMOND C DUHAMEL
Correspondent
C.R. Bard, Inc.
169 New Boston St.
Woburn,  MA 
Correspondent Contact RAYMOND C DUHAMEL
Regulation Number870.3450
Classification Product Code
DSY  
Date Received02/22/1994
Decision Date 06/02/1994
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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