MINUTEMAN CO2 MICROSURGICAL LASER OTO— 510(k) K843514

Name: FDA 510(k) clearance K843514
Creator: U.S. Food and Drug Administration
Published: 1984-12-04

Substantially Equivalent

American Surgical Laser, Inc.

FDA 510(k) clearance K843514 for MINUTEMAN CO2 MICROSURGICAL LASER OTO, Substantially Equivalent on 1984-12-04. Applicant: American Surgical Laser, Inc.. Device class: 2.

Clearance details

Applicant: American Surgical Laser, Inc.
Product code: Code EWG
Device class: Class 2
Regulation: 21 CFR 874.4500
Advisory panel: Ear, Nose, Throat
Date received: 1984-09-05
Decision date: 1984-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, 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.