ALPHASPHERE ORBITAL IMPLANT— 510(k) K053298

Substantially Equivalent

Hydron Pty Limited

FDA 510(k) clearance K053298 for ALPHASPHERE ORBITAL IMPLANT, Substantially Equivalent on 2006-05-09. Applicant: Hydron Pty Limited. Device class: 2.

Clearance details

Applicant: Hydron Pty Limited
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 2005-11-25
Decision date: 2006-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Beach, CA, 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.