ELLEX SLIT LAMP, MODEL 30XL— 510(k) K063352

Name: FDA 510(k) clearance K063352
Creator: U.S. Food and Drug Administration
Published: 2007-03-13

Substantially Equivalent

Takagi Seiko Co., Ltd.

FDA 510(k) clearance K063352 for ELLEX SLIT LAMP, MODEL 30XL, Substantially Equivalent on 2007-03-13. Applicant: Takagi Seiko Co., Ltd.. Device class: 2.

Clearance details

Applicant: Takagi Seiko Co., Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2006-11-06
Decision date: 2007-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Adelaide, South Australia, AU

Download summary PDF View on FDA.gov ↗

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