SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500— 510(k) K093639

Name: FDA 510(k) clearance K093639
Creator: U.S. Food and Drug Administration
Published: 2009-12-03

Substantially Equivalent

Huvitz Co., Ltd.

FDA 510(k) clearance K093639 for SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500, Substantially Equivalent on 2009-12-03. Applicant: Huvitz Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huvitz Co., Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2009-11-24
Decision date: 2009-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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