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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name treadmill, powered
510(k) Number K904556
Device Name MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
Applicant
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact JEANNE M LESNIAK
Correspondent
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact JEANNE M LESNIAK
Regulation Number890.5380
Classification Product Code
IOL  
Date Received10/05/1990
Decision Date 12/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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