The following data is part of a premarket notification filed by Product And Educational Services Llc with the FDA for Eye Spheres.
| Device ID | K082850 |
| 510k Number | K082850 |
| Device Name: | EYE SPHERES |
| Classification | Implant, Eye Sphere |
| Applicant | PRODUCT AND EDUCATIONAL SERVICES LLC 3805 OLD EASTON ROAD Dolyestown, PA 18902 |
| Contact | Edward Griffith |
| Correspondent | Edward Griffith PRODUCT AND EDUCATIONAL SERVICES LLC 3805 OLD EASTON ROAD Dolyestown, PA 18902 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2009-02-27 |
| Summary: | summary |