PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER— 510(k) K915068

Name: FDA 510(k) clearance K915068
Creator: U.S. Food and Drug Administration
Published: 1992-02-06

Substantially Equivalent

American Medical Mfg., Inc.

FDA 510(k) clearance K915068 for PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER, Substantially Equivalent on 1992-02-06. Applicant: American Medical Mfg., Inc.. Device class: 2.

Clearance details

Applicant: American Medical Mfg., Inc.
Product code: Code FTA
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1991-11-08
Decision date: 1992-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calabasas, CA, 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.