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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 K933204
Device Name BARD PTFE VASCULAR GRAFT
Applicant
C.R. BARD, INC.
129 CONCORD RD.
P.O. BOX 566
BILLERICA,  MA  01821
Applicant Contact HANS BEINKE
Correspondent
C.R. BARD, INC.
129 CONCORD RD.
P.O. BOX 566
BILLERICA,  MA  01821
Correspondent Contact HANS BEINKE
Regulation Number870.3450
Classification Product Code
DSY  
Date Received07/01/1993
Decision Date 10/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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