LEKSELL STEREOTACTIC SYSTEM— 510(k) K802140

Name: FDA 510(k) clearance K802140
Creator: U.S. Food and Drug Administration
Published: 1981-02-05

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K802140 for LEKSELL STEREOTACTIC SYSTEM, Substantially Equivalent on 1981-02-05. Applicant: Downs Surgical , Ltd.. Device class: 1.

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code IWY
Device class: Class 1
Regulation: 21 CFR 892.1920
Advisory panel: Radiology
Date received: 1980-09-04
Decision date: 1981-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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