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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
Recalls CDRH Recalls
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