ORBITAL RECONSTRUCTIVE IMPLANT II— 510(k) K083342

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..

Clearance details

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

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