M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM— 510(k) K951424

Name: FDA 510(k) clearance K951424
Creator: U.S. Food and Drug Administration
Published: 1995-05-09

Substantially Equivalent

M.E.R. Surgical Co.

FDA 510(k) clearance K951424 for M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM, Substantially Equivalent on 1995-05-09. Applicant: M.E.R. Surgical Co.. Device class: 2.

Clearance details

Applicant: M.E.R. Surgical Co.
Product code: Code EOX
Device class: Class 2
Regulation: 21 CFR 874.4710
Advisory panel: Ear, Nose, Throat
Date received: 1995-03-27
Decision date: 1995-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut, CA, US

Download summary PDF View on FDA.gov ↗

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