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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
Applicant
Onset Medical Corporation
13900 Alton Pkwy. Suite 120
Irvine,  CA  92618
Applicant Contact JOSEPH BISHOP
Correspondent
Onset Medical Corporation
13900 Alton Pkwy. Suite 120
Irvine,  CA  92618
Correspondent Contact JOSEPH BISHOP
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/10/2012
Decision Date 05/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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