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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K855126
Device Name CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
Original Applicant
CORDIS CORP.
post office box 025700
miami,  FL  33102 -5700
Original Contact donna l rogers
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/23/1985
Decision Date 02/26/1986
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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