The following data is part of a premarket notification filed by Oculo Plastik, Inc. with the FDA for Silicone Spheres.
| Device ID | K112176 |
| 510k Number | K112176 |
| Device Name: | SILICONE SPHERES |
| Classification | Implant, Eye Sphere |
| Applicant | OCULO PLASTIK, INC. 200 SAUVE WEST Montreal, Qc, CA H3l 1y9 |
| Contact | Sylvain Desrosiers |
| Correspondent | Sylvain Desrosiers OCULO PLASTIK, INC. 200 SAUVE WEST Montreal, Qc, CA H3l 1y9 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-28 |
| Decision Date | 2011-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190660036065 | K112176 | 000 |
| M8721121403 | K112176 | 000 |
| M8721121504 | K112176 | 000 |
| 10697660000197 | K112176 | 000 |
| 10697660000210 | K112176 | 000 |
| 10697660000234 | K112176 | 000 |
| 10697660000258 | K112176 | 000 |
| 10697660000296 | K112176 | 000 |
| 00190660036027 | K112176 | 000 |
| 00190660036034 | K112176 | 000 |
| 00190660036041 | K112176 | 000 |
| 00190660036058 | K112176 | 000 |
| 10697660000135 | K112176 | 000 |