BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080— 510(k) K000544

Name: FDA 510(k) clearance K000544
Creator: U.S. Food and Drug Administration
Published: 2000-03-09

Substantially Equivalent

Labtician Ophthalmics, Inc.

FDA 510(k) clearance K000544 for BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080, Substantially Equivalent on 2000-03-09. Applicant: Labtician Ophthalmics, Inc.. Device class: 1.

Clearance details

Applicant: Labtician Ophthalmics, Inc.
Product code: Code HJX
Device class: Class 1
Regulation: 21 CFR 886.5810
Advisory panel: Ophthalmic
Date received: 2000-02-18
Decision date: 2000-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, Ontario, CA

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