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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Graft, Vascular, Synthetic/Biologic Composite
510(k) Number K954848
Device Name HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
Applicant
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
112 BAUER DR.
OAKLAND,  NJ  07436
Applicant Contact CAROLYN TAUBER
Correspondent
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
112 BAUER DR.
OAKLAND,  NJ  07436
Correspondent Contact CAROLYN TAUBER
Regulation Number870.3450
Classification Product Code
MAL  
Date Received10/23/1995
Decision Date 02/01/1996
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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