The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Landers Vitrectomy Lens Ring Systems.
| Device ID | K850991 |
| 510k Number | K850991 |
| Device Name: | LANDERS VITRECTOMY LENS RING SYSTEMS |
| Classification | Ring, Ophthalmic (flieringa) |
| Applicant | OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
| Contact | Tamsin J Erickson |
| Correspondent | Tamsin J Erickson OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
| Product Code | HNH |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-11 |
| Decision Date | 1985-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630238008389 | K850991 | 000 |