LEKSELL STEREOACTIC SYSTEM— 510(k) K811726

Name: FDA 510(k) clearance K811726
Creator: U.S. Food and Drug Administration
Published: 1981-07-10

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K811726 for LEKSELL STEREOACTIC SYSTEM, Substantially Equivalent on 1981-07-10. Applicant: Downs Surgical , Ltd.. Device class: 2.

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code LHF
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1981-06-18
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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