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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K112629
Device Name ONSET ACCESS CATHETER 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 Number870.1250
Classification Product Code
DQY  
Date Received09/09/2011
Decision Date 10/11/2011
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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