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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mini Endoscope, Gastroenterology-Urology
510(k) Number K050403
Device Name SPYGLASS DIRECT VISULATION PROBE
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK,  MA  01760 -1537
Applicant Contact KATHLEEN MORAHAN
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number876.1500
Classification Product Code
ODF  
Subsequent Product Code
FDT  
Date Received02/17/2005
Decision Date 03/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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