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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 K895433
Device Name ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS
Applicant
Aries Medical, Inc.
Two Gill St.
Woburn,  MA  01801
Applicant Contact BARRY V ASHAR
Correspondent
Aries Medical, Inc.
Two Gill St.
Woburn,  MA  01801
Correspondent Contact BARRY V ASHAR
Regulation Number870.3535
Classification Product Code
DSP  
Date Received09/07/1989
Decision Date 04/10/1990
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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