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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name temporary coronary saphenous vein bypass graft for embolic protection
510(k) Number K051179
Device Name EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
Applicant
BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW,  CA  94043 -4655
Applicant Contact CATHERINE A PETERS
Correspondent
BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW,  CA  94043 -4655
Correspondent Contact CATHERINE A PETERS
Regulation Number870.1250
Classification Product Code
NFA  
Date Received05/09/2005
Decision Date 06/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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