ACUFEX FIXATION BUTTON— 510(k) K884565

Name: FDA 510(k) clearance K884565
Creator: U.S. Food and Drug Administration
Published: 1989-02-27

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K884565 for ACUFEX FIXATION BUTTON, Substantially Equivalent on 1989-02-27. Applicant: Acufex Microsurgical, Inc.. Device class: 1.

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code KGS
Device class: Class 1
Regulation: 21 CFR 878.4930
Advisory panel: General, Plastic Surgery
Date received: 1988-11-01
Decision date: 1989-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, 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.