ACUFEX ARTHROSCOPIC SHAVER— 510(k) K844130

Name: FDA 510(k) clearance K844130
Creator: U.S. Food and Drug Administration
Published: 1985-03-21

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K844130 for ACUFEX ARTHROSCOPIC SHAVER, Substantially Equivalent on 1985-03-21. 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: 1984-10-23
Decision date: 1985-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

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