MITEK MODULAR DRILL BIT— 510(k) K935225

Name: FDA 510(k) clearance K935225
Creator: U.S. Food and Drug Administration
Published: 1994-04-07

Substantially Equivalent

Mitek Surgical Products, Inc.

FDA 510(k) clearance K935225 for MITEK MODULAR DRILL BIT, Substantially Equivalent on 1994-04-07. Applicant: Mitek Surgical Products, Inc.. Device class: 1.

Clearance details

Applicant: Mitek Surgical Products, Inc.
Product code: Code GFG
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1993-11-01
Decision date: 1994-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.