The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Landers Indirect Vitrectomy Lens.
| Device ID | K864418 |
| 510k Number | K864418 |
| Device Name: | LANDERS INDIRECT VITRECTOMY LENS |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| 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 | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-10 |
| Decision Date | 1986-11-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630238079594 | K864418 | 000 |
| 00630238064736 | K864418 | 000 |
| 00630238064231 | K864418 | 000 |
| 00630238055796 | K864418 | 000 |
| 00630238052429 | K864418 | 000 |
| 00630238008877 | K864418 | 000 |
| 00630238008747 | K864418 | 000 |
| 00630238008419 | K864418 | 000 |
| 00630238008402 | K864418 | 000 |
| 00630238008396 | K864418 | 000 |
| 00630238006767 | K864418 | 000 |
| 00630238006736 | K864418 | 000 |
| 00630238006729 | K864418 | 000 |
| 00630238006712 | K864418 | 000 |
| 00630238065603 | K864418 | 000 |
| 00630238065610 | K864418 | 000 |
| 00630238079587 | K864418 | 000 |
| 00630238079440 | K864418 | 000 |
| 00630238079303 | K864418 | 000 |
| 00630238074087 | K864418 | 000 |
| 00630238066709 | K864418 | 000 |
| 00630238066693 | K864418 | 000 |
| 00630238066686 | K864418 | 000 |
| 00630238066679 | K864418 | 000 |
| 00630238066662 | K864418 | 000 |
| 00630238066655 | K864418 | 000 |
| 00630238066648 | K864418 | 000 |
| 00630238066631 | K864418 | 000 |
| 00630238065627 | K864418 | 000 |
| 00630238006705 | K864418 | 000 |