SILICONE SPHERES— 510(k) K112176

Substantially Equivalent

Oculo Plastik, Inc.

FDA 510(k) clearance K112176 for SILICONE SPHERES, Substantially Equivalent on 2011-09-15. 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: 2011-07-28
Decision date: 2011-09-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Montreal, Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code HPZ

K212741 — EZYPOR2022-06-24
K123764 — DURETTE OCULAR IMPLANT2013-01-31
K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX2011-11-02
K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II2009-03-12
K082850 — EYE SPHERES2009-02-27

More clearances from Oculo Plastik, Inc.

K073293 — DURETTE IMPLANT2008-03-19
K040689 — EYE SPHERE IMPLANTS2004-06-10
K934834 — EPTFE SHEET COVERING FOR OCULAR IMPLANT1994-05-05
K915630 — OPHTIMPLANT1992-03-02
K901002 — O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES1990-05-22

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