SPECTACLE SUNGLASSES(NON-PRESCRIPTION)— 510(k) K953629

Name: FDA 510(k) clearance K953629
Creator: U.S. Food and Drug Administration
Published: 1995-08-23

Substantially Equivalent

Lowinger Holdings, Inc.

FDA 510(k) clearance K953629 for SPECTACLE SUNGLASSES(NON-PRESCRIPTION), Substantially Equivalent on 1995-08-23. Applicant: Lowinger Holdings, Inc.. Device class: 1.

Clearance details

Applicant: Lowinger Holdings, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1995-07-24
Decision date: 1995-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aventura, FL, US

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