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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 K862464
Device Name SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR
Original Applicant
SHILEY, INC.
17600 gillette ave.
p.o. box 19503
irvine,  CA  92714
Original Contact radine pobuda
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/30/1986
Decision Date 08/28/1986
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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