ARCTIC PREMIER SERIES— 510(k) K944700

Substantially Equivalent

Sungold Eyewear, Inc.

FDA 510(k) clearance K944700 for ARCTIC PREMIER SERIES, Substantially Equivalent on 1994-12-22. Applicant: Sungold Eyewear, Inc.. Device class: 1.

Clearance details

Applicant: Sungold Eyewear, Inc.
Product code: Code HOY
Device class: Class 1
Regulation: 21 CFR 886.4750
Advisory panel: Ophthalmic
Date received: 1994-09-23
Decision date: 1994-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kent, WA, US

Download summary PDF View on FDA.gov ↗

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K945351 — SHIELD, EYE, OPHTHALMIC1994-12-13

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