ACUFEX ROTATOR CUFF FIXATION BUTTON— 510(k) K941740

Name: FDA 510(k) clearance K941740
Creator: U.S. Food and Drug Administration
Published: 1995-06-30

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K941740 for ACUFEX ROTATOR CUFF FIXATION BUTTON, Substantially Equivalent on 1995-06-30. 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: 1994-04-07
Decision date: 1995-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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