SUNGLASSES— 510(k) K910329

Substantially Equivalent

Cutler & Gross Sloan Optical , Ltd.

FDA 510(k) clearance K910329 for SUNGLASSES, Substantially Equivalent on 1991-03-12. Applicant: Cutler & Gross Sloan Optical , Ltd.. Device class: 1.

Clearance details

Applicant: Cutler & Gross Sloan Optical , Ltd.
Product code: Code HOI
Device class: Class 1
Regulation: 21 CFR 886.5840
Advisory panel: Ophthalmic
Date received: 1991-01-25
Decision date: 1991-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: England, GB

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K854854 — SYSTEMS OF SIGHT LOW VISION EYEWARE1986-02-04
K844716 — MAGNIFYING SPECTACLES W/PLASTIC LENSES1985-01-03

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