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510(k) K904556

MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB by Boston Scientific Corp — Product Code IOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1991
Date Received
October 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Treadmill, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

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