RSH BILIARY STONE REMOVAL DEVICE— 510(k) K131642

Substantially Equivalent

Rsh, LLC

FDA 510(k) clearance K131642 for RSH BILIARY STONE REMOVAL DEVICE, Substantially Equivalent on 2013-08-07. Applicant: Rsh, LLC. Device class: 2.

Clearance details

Applicant: Rsh, LLC
Product code: Code LQR
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-04
Decision date: 2013-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.