EYE SPHERE, CONFORMERS— 510(k) K972661

Substantially Equivalent

Gulden Ophthalmics

FDA 510(k) clearance K972661 for EYE SPHERE, CONFORMERS, Substantially Equivalent on 1997-10-03. Applicant: Gulden Ophthalmics. Device class: 2.

Clearance details

Applicant: Gulden Ophthalmics
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 1997-07-16
Decision date: 1997-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkins Park, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.