TENET TIBIAL FRACTURE SUPPORT— 510(k) K964102

Name: FDA 510(k) clearance K964102
Creator: U.S. Food and Drug Administration
Published: 1996-12-05

Substantially Equivalent

Tenet Medical Engineering

FDA 510(k) clearance K964102 for TENET TIBIAL FRACTURE SUPPORT, Substantially Equivalent on 1996-12-05. Applicant: Tenet Medical Engineering. Device class: 1.

Clearance details

Applicant: Tenet Medical Engineering
Product code: Code GBB
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1996-10-11
Decision date: 1996-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary Alberta, CA

Download summary PDF View on FDA.gov ↗

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