EYE SPHERES— 510(k) K082850

Name: FDA 510(k) clearance K082850
Creator: U.S. Food and Drug Administration
Published: 2009-02-27

Substantially Equivalent

Product and Educational Services, LLC

FDA 510(k) clearance K082850 for EYE SPHERES, Substantially Equivalent on 2009-02-27. Applicant: Product and Educational Services, LLC. Device class: 2.

Clearance details

Applicant: Product and Educational Services, LLC
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 2008-09-29
Decision date: 2009-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doylestown, PA, US

Download summary PDF View on FDA.gov ↗

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