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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 K091495
Device Name SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact STACY ABBATIELLO
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact STACY ABBATIELLO
Regulation Number876.5010
Classification Product Code
LQR  
Subsequent Product Code
FGE  
Date Received05/20/2009
Decision Date 09/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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