STABLELOC II EXTERNAL FIXATOR— 510(k) K965029

Substantially Equivalent

Acu Med, Inc.

FDA 510(k) clearance K965029 for STABLELOC II EXTERNAL FIXATOR, Substantially Equivalent on 1997-02-19. 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: 1996-12-17
Decision date: 1997-02-19
Decision: Substantially Equivalent
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.