LITHOTRIPTOR SYSTEM MODEL 27080— 510(k) K905553

Name: FDA 510(k) clearance K905553
Creator: U.S. Food and Drug Administration
Published: 1991-06-04

Substantially Equivalent

Karl Storz GmbH & Co. (Kst)

FDA 510(k) clearance K905553 for LITHOTRIPTOR SYSTEM MODEL 27080, Substantially Equivalent on 1991-06-04. Applicant: Karl Storz GmbH & Co. (Kst). Device class: 2.

Clearance details

Applicant: Karl Storz GmbH & Co. (Kst)
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1990-12-11
Decision date: 1991-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

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