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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic ultrasound system, gastroenterology-urology
510(k) Number K110030
Device Name EXPECT ENDOSCOPIC ASPIRATION NEEDLE
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact ASHLEY PYLE
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact PAULA WILKERSON
Regulation Number876.1500
Classification Product Code
ODG  
Date Received01/05/2011
Decision Date 01/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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