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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 K961847
Device Name HEMASHIELD VANTAGE (VASCULAR GRAFT
Applicant
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
103 BAUER DR.
P.O. BOX 530
OAKLAND,  NJ  07436
Applicant Contact CAROLYN TAUBER
Correspondent
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
103 BAUER DR.
P.O. BOX 530
OAKLAND,  NJ  07436
Correspondent Contact CAROLYN TAUBER
Regulation Number870.3450
Classification Product Code
DSY  
Date Received05/13/1996
Decision Date 01/22/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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