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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 K121404
Device Name SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
Original Applicant
ONSET MEDICAL CORPORATION
13900 alton parkway, suite 120
irvine,  CA  92618
Original Contact joseph bishop
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/31/2012
Decision Date 05/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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