EXTERNAL FIXATOR— 510(k) K943857

Name: FDA 510(k) clearance K943857
Creator: U.S. Food and Drug Administration
Published: 1995-01-27

Substantially Equivalent for Some Indications

Acu Med, Inc.

FDA 510(k) clearance K943857 for EXTERNAL FIXATOR, Substantially Equivalent for Some Indications on 1995-01-27. Applicant: Acu Med, Inc.. Device class: 2.

Clearance details

Applicant: Acu Med, Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1994-08-08
Decision date: 1995-01-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.