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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name patch, pledget and intracardiac, petp, ptfe, polypropylene
510(k) Number K955349
Device Name HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
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 Number870.3470
Classification Product Code
DXZ  
Date Received11/21/1995
Decision Date 02/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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