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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 K950687
Device Name EXTERNAL HELIUM SUPPLY (ACCESSORY FOR 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 Received02/14/1995
Decision Date 05/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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