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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, biopsy, endomyocardial
510(k) Number K973818
Device Name T-REX BIOPSY FORCEPS
Applicant
BOSTON SCIENTIFIC CORP.
17425 NORTH EAST UNION HILL RD
NORTHWEST TECHNOLOGY CENTER
REDMOND,  WA  98052 -3376
Applicant Contact JOCELYN KERSTEN
Correspondent
BOSTON SCIENTIFIC CORP.
17425 NORTH EAST UNION HILL RD
NORTHWEST TECHNOLOGY CENTER
REDMOND,  WA  98052 -3376
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received10/07/1997
Decision Date 12/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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