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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 K954582
Device Name BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
Applicant
C.R. Bard, Inc.
25 Computer Dr.
Haverhill,  MA  01832
Applicant Contact RAYMOND C DUHAMEL
Correspondent
C.R. Bard, Inc.
25 Computer Dr.
Haverhill,  MA  01832
Correspondent Contact RAYMOND C DUHAMEL
Regulation Number870.3450
Classification Product Code
DSY  
Date Received09/07/1995
Decision Date 12/07/1995
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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