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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 K973401
Device Name TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact JACQUELINE ZIMOVAN
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact JACQUELINE ZIMOVAN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/09/1997
Decision Date 11/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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