GAYHEART CORNEAL EXCISION DEVICE— 510(k) K022843

Name: FDA 510(k) clearance K022843
Creator: U.S. Food and Drug Administration
Published: 2002-11-01

Substantially Equivalent

Stephens Instruments

FDA 510(k) clearance K022843 for GAYHEART CORNEAL EXCISION DEVICE, Substantially Equivalent on 2002-11-01. Applicant: Stephens Instruments. Device class: 1.

Clearance details

Applicant: Stephens Instruments
Product code: Code HRH
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 2002-08-27
Decision date: 2002-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, KY, US

Download summary PDF View on FDA.gov ↗

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