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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K151610
Device Name Comet Pressure Guidewire
Applicant
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Applicant Contact JAMES KLEINEDLER
Correspondent
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Correspondent Contact JAMES KLEINEDLER
Regulation Number870.2870
Classification Product Code
DXO  
Date Received06/15/2015
Decision Date 10/06/2015
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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