SPECTACLE SUN GLASSES (NON PRESCRIPTION)— 510(k) K934081

Name: FDA 510(k) clearance K934081
Creator: U.S. Food and Drug Administration
Published: 1993-10-18

Substantially Equivalent

South American Optical, Inc.

FDA 510(k) clearance K934081 for SPECTACLE SUN GLASSES (NON PRESCRIPTION), Substantially Equivalent on 1993-10-18. Applicant: South American Optical, Inc.. Device class: 1.

Clearance details

Applicant: South American Optical, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1993-08-20
Decision date: 1993-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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