MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE— 510(k) K862866

Name: FDA 510(k) clearance K862866
Creator: U.S. Food and Drug Administration
Published: 1987-01-09

Substantially Equivalent

Directed Energy, Inc.

FDA 510(k) clearance K862866 for MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE, Substantially Equivalent on 1987-01-09. 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: 1986-07-29
Decision date: 1987-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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