FIBER OPTIC LIGHT SOURCE— 510(k) K801176

Name: FDA 510(k) clearance K801176
Creator: U.S. Food and Drug Administration
Published: 1980-05-28

Substantially Equivalent

Aspen Laboratories, Inc.

FDA 510(k) clearance K801176 for FIBER OPTIC LIGHT SOURCE, Substantially Equivalent on 1980-05-28. Applicant: Aspen Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Aspen Laboratories, Inc.
Product code: Code EQH
Device class: Class 1
Regulation: 21 CFR 874.4350
Advisory panel: Ear, Nose, Throat
Date received: 1980-05-16
Decision date: 1980-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.