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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 K770821
Device Name PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT
Applicant
AVCO MEDICAL PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AVCO MEDICAL PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.3535
Classification Product Code
DSP  
Date Received05/04/1977
Decision Date 05/06/1977
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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