OPTIKOS SHAMI, INC. SPECTACLE FRAMES— 510(k) K934198

Name: FDA 510(k) clearance K934198
Creator: U.S. Food and Drug Administration
Published: 1993-10-04

Substantially Equivalent

Optikos Shami, Inc.

FDA 510(k) clearance K934198 for OPTIKOS SHAMI, INC. SPECTACLE FRAMES, Substantially Equivalent on 1993-10-04. Applicant: Optikos Shami, Inc.. Device class: 1.

Clearance details

Applicant: Optikos Shami, Inc.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1993-08-26
Decision date: 1993-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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