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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 K131642
Device Name RSH BILIARY STONE REMOVAL DEVICE
Applicant
Rsh, LLC
5121 Feagan St.
Houston,  TX  77007
Applicant Contact AMY SPRINGS
Correspondent
Rsh, LLC
5121 Feagan St.
Houston,  TX  77007
Correspondent Contact AMY SPRINGS
Regulation Number876.5010
Classification Product Code
LQR  
Subsequent Product Code
FGE  
Date Received06/04/2013
Decision Date 08/07/2013
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
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