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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K960975
Device Name 1-4F INFINITI ANGIOGRAPHIC CATHETER
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact JODI LYNN FRASIER
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact JODI LYNN FRASIER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/11/1996
Decision Date 04/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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