AGEE EXTERNAL FIXATOR— 510(k) K842493

Name: FDA 510(k) clearance K842493
Creator: U.S. Food and Drug Administration
Published: 1985-02-13

Substantially Equivalent

The Hand Biomechanics Research Laboratory

FDA 510(k) clearance K842493 for AGEE EXTERNAL FIXATOR, Substantially Equivalent on 1985-02-13. Applicant: The Hand Biomechanics Research Laboratory. Device class: 2.

Clearance details

Applicant: The Hand Biomechanics Research Laboratory
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1984-06-26
Decision date: 1985-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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