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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Biliary
510(k) Number K071066
Device Name SPYCATCH STONE RETRIEVAL BASKET
Applicant
Boston Scientific Corp
100 Boston Scientific Way
Mailstop M11
Marlborough,  MA  01752
Applicant Contact NEIL KELLY
Correspondent
Boston Scientific Corp
100 Boston Scientific Way
Mailstop M11
Marlborough,  MA  01752
Correspondent Contact NEIL KELLY
Regulation Number876.5010
Classification Product Code
LQR  
Date Received04/16/2007
Decision Date 06/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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