OXFORD EXTERNAL FIXATION SYSTEM— 510(k) K800184

Name: FDA 510(k) clearance K800184
Creator: U.S. Food and Drug Administration
Published: 1980-02-11

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K800184 for OXFORD EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 1980-02-11. Applicant: Downs Surgical , Ltd.. Device class: 2.

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1980-01-29
Decision date: 1980-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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