QRK 100, QUALITATIVE RING KERATOSCOPE— 510(k) K882902

Name: FDA 510(k) clearance K882902
Creator: U.S. Food and Drug Administration
Published: 1988-08-04

Substantially Equivalent

Technitex, Inc.

FDA 510(k) clearance K882902 for QRK 100, QUALITATIVE RING KERATOSCOPE, Substantially Equivalent on 1988-08-04. Applicant: Technitex, Inc.. Device class: 1.

Clearance details

Applicant: Technitex, Inc.
Product code: Code HLR
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1988-07-12
Decision date: 1988-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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K854054 — PLACIDO DISC1985-12-27
K830008 — KARICKHOFF KERATOSCOPE1983-01-26

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Data sourced from openFDA. This site is unofficial and independent of the FDA.