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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 K863537
Device Name CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY
Applicant
CORDIS CORP.
P.O. BOX 025700
MIAMI,  FL  33102
Applicant Contact HENNEMANN, PHD
Correspondent
CORDIS CORP.
P.O. BOX 025700
MIAMI,  FL  33102
Correspondent Contact HENNEMANN, PHD
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/11/1986
Decision Date 10/31/1986
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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