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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 K052194
Device Name SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
Applicant
Boston Scientific Corp
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact ALLYSON BARFORD
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact DANIEL W LEHTONEN
Regulation Number876.1500
Classification Product Code
ODF  
Subsequent Product Code
FDT  
Date Received08/11/2005
Decision Date 08/24/2005
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
Recalls CDRH Recalls
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