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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name injector and syringe, angiographic
510(k) Number K834107
Device Name ANGIOPLASTY INFLATION DEVICE & CARTR
Applicant
CORDIS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CORDIS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1650
Classification Product Code
DXT  
Date Received11/29/1983
Decision Date 01/13/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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