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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, electrode recording, or probe, electrode recording
510(k) Number K000753
Device Name CORDIS 13F CATHETER SHEATH INTRODUCER
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact ARIEL MACTAVISH
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact ARIEL MACTAVISH
Regulation Number870.1220
Classification Product Code
DRF  
Date Received03/08/2000
Decision Date 04/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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