LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER— 510(k) K974796

Name: FDA 510(k) clearance K974796
Creator: U.S. Food and Drug Administration
Published: 1998-03-12

Substantially Equivalent

Medispec, Ltd.

FDA 510(k) clearance K974796 for LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER, Substantially Equivalent on 1998-03-12. Applicant: Medispec, Ltd.. Device class: 2.

Clearance details

Applicant: Medispec, Ltd.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1997-12-22
Decision date: 1998-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montgomery Village, MD, 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.