POLARIS SPECTACLE FRAMES & LENSES— 510(k) K802082

Name: FDA 510(k) clearance K802082
Creator: U.S. Food and Drug Administration
Published: 1981-02-13

Substantially Equivalent

Polaris Optics USA, Inc.

FDA 510(k) clearance K802082 for POLARIS SPECTACLE FRAMES & LENSES, Substantially Equivalent on 1981-02-13. Applicant: Polaris Optics USA, Inc.. Device class: 1.

Clearance details

Applicant: Polaris Optics USA, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1980-08-28
Decision date: 1981-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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