UVEX ALPHA, BETA, GAMMA & DELTA SUN— 510(k) K820016

Name: FDA 510(k) clearance K820016
Creator: U.S. Food and Drug Administration
Published: 1982-03-19

Substantially Equivalent

Bacou USA, Inc. and Uvex Safety, Inc.

FDA 510(k) clearance K820016 for UVEX ALPHA, BETA, GAMMA & DELTA SUN, Substantially Equivalent on 1982-03-19. Applicant: Bacou USA, Inc. and Uvex Safety, Inc.. Device class: 1.

Clearance details

Applicant: Bacou USA, Inc. and Uvex Safety, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1982-01-05
Decision date: 1982-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K974861 — NON-PRESCRIPTION SUNGLASSES1998-01-27
K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

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