DURETTE IMPLANT— 510(k) K073293

Substantially Equivalent

Oculo Plastik, Inc.

FDA 510(k) clearance K073293 for DURETTE IMPLANT, Substantially Equivalent on 2008-03-19. Applicant: Oculo Plastik, Inc.. Device class: 2.

Clearance details

Applicant: Oculo Plastik, Inc.
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 2007-11-23
Decision date: 2008-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, Quebec, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Oculo Plastik, Inc.

K040689 — EYE SPHERE IMPLANTS2004-06-10
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K901002 — O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES1990-05-22
K900929 — PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL1990-05-18

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