ARTUS DISPOSABLE SHEATHS/CUTTERS— 510(k) K880881

Name: FDA 510(k) clearance K880881
Creator: U.S. Food and Drug Administration
Published: 1988-05-04

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K880881 for ARTUS DISPOSABLE SHEATHS/CUTTERS, Substantially Equivalent on 1988-05-04. Applicant: Acufex Microsurgical, Inc.. Device class: 1.

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1988-03-02
Decision date: 1988-05-04
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.