Oculo Plastik, Inc.
MONTREAL Quebec, CA
OCULO PLASTIK, INC. appears in FDA device records in MONTREAL Quebec, CA. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Oculo Plastik, Inc. between 1990 and 2013. The busiest year on record is 1990, with 7. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 7 |
| 1992 | 1 |
| 1994 | 1 |
| 2004 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123764 | DURETTE OCULAR IMPLANT | HPZ | Substantially Equivalent | |
| K112176 | SILICONE SPHERES | HPZ | Substantially Equivalent | |
| K073293 | DURETTE IMPLANT | HPZ | Substantially Equivalent | |
| K040689 | EYE SPHERE IMPLANTS | HPZ | Substantially Equivalent | |
| K934834 | EPTFE SHEET COVERING FOR OCULAR IMPLANT | HPZ | Substantially Equivalent | |
| K915630 | OPHTIMPLANT | HPZ | Substantially Equivalent | |
| K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | HQX | Substantially Equivalent | |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | HQX | Substantially Equivalent | |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | HQX | Substantially Equivalent | |
| K900928 | COX MALAR EMINENCE IMPLANTS | HQX | Substantially Equivalent | |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | HQX | Substantially Equivalent | |
| K900081 | NEW ALLEN IMPLANT | HPZ | Substantially Equivalent | |
| K900080 | NEW IOWA MOTILITY IMPLANT | HPZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8022166 | 3002513507 | OCULO PLASTIK, INC. | 200 SAUVE WEST, MONTREAL Quebec H3L 1Y9 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GDJClamp, Surgical, General & Plastic Surgery
- HQNConformer, Ophthalmic
- HPZImplant, Eye Sphere
- HQXImplant, Orbital, Extra-Ocular
- KYEInserter/Remover Contact Lens
- BRWProtector, Dental
- GADRetractor
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- IWSShield, Eye, Radiological
- FTYTape, Measuring, Rulers And Calipers
- EGDWax, Dental, Intraoral
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain