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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 K051679
Device Name ILAB ULTRASOUND IMAGING SYSTEM
Applicant
Boston Scientific Corp
47201 Lakeview Blvd.
Fremont,  CA  94537
Applicant Contact ROBERT Z PHILLIPS
Correspondent
Boston Scientific Corp
47201 Lakeview Blvd.
Fremont,  CA  94537
Correspondent Contact ROBERT Z PHILLIPS
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received06/23/2005
Decision Date 07/14/2005
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
Recalls CDRH Recalls
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