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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K982538
Device Name BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP
Applicant
Belmont Instrument Corp.
780 Boston Rd.
Billerica,  MA  01821
Applicant Contact URAIWAN P LABADINI
Correspondent
Belmont Instrument Corp.
780 Boston Rd.
Billerica,  MA  01821
Correspondent Contact URAIWAN P LABADINI
Regulation Number870.3535
Classification Product Code
DSP  
Date Received07/21/1998
Decision Date 10/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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