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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 K913801
Device Name CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL
Original Applicant
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes,  FL  33014
Original Contact mirjam barboza
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/26/1991
Decision Date 10/16/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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