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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 K060927
Device Name CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES
Applicant
Ceres Medical Systems, LLC
13195 Seagrove St.
San Diego,  CA  92130
Applicant Contact CORRINE BONFIGLIO
Correspondent
Ceres Medical Systems, LLC
13195 Seagrove St.
San Diego,  CA  92130
Correspondent Contact CORRINE BONFIGLIO
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/04/2006
Decision Date 10/06/2006
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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