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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K101138
Device Name SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
Applicant
Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Applicant Contact MELISSA C SCHULTZ, RAC, MMS
Correspondent
Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Correspondent Contact MELISSA C SCHULTZ, RAC, MMS
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received04/22/2010
Decision Date 06/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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