ORBITAL RECONSTRUCTIVE IMPLANT II— 510(k) K083342

Name: FDA 510(k) clearance K083342
Creator: U.S. Food and Drug Administration
Published: 2009-03-12

Substantially Equivalent

Evera Medical, Inc.

FDA 510(k) clearance K083342 for ORBITAL RECONSTRUCTIVE IMPLANT II, Substantially Equivalent on 2009-03-12. Applicant: Evera Medical, Inc.. Device class: 2.

Clearance details

Applicant: Evera Medical, Inc.
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 2008-11-12
Decision date: 2009-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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