MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)— 510(k) K862150

Name: FDA 510(k) clearance K862150
Creator: U.S. Food and Drug Administration
Published: 1986-09-04

Substantially Equivalent for Some Indications

Directed Energy, Inc.

FDA 510(k) clearance K862150 for MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT), Substantially Equivalent for Some Indications on 1986-09-04. Applicant: Directed Energy, Inc.. Device class: 2.

Clearance details

Applicant: Directed Energy, Inc.
Product code: Code EWG
Device class: Class 2
Regulation: 21 CFR 874.4500
Advisory panel: Ear, Nose, Throat
Date received: 1986-06-04
Decision date: 1986-09-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Los Angeles, CA, US

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