HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)— 510(k) K063498

Name: FDA 510(k) clearance K063498
Creator: U.S. Food and Drug Administration
Published: 2007-06-11

Substantially Equivalent

Sebia

FDA 510(k) clearance K063498 for HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356), Substantially Equivalent on 2007-06-11. Applicant: Sebia. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code OBZ
Device class: Class 2
Regulation: 21 CFR 866.5130
Advisory panel: Immunology
Date received: 2006-11-20
Decision date: 2007-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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