The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Disposable Vitrectomy Lens.
| Device ID | K012096 |
| 510k Number | K012096 |
| Device Name: | DISPOSABLE VITRECTOMY LENS |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
| Contact | Raymond Graham |
| Correspondent | Raymond Graham OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-05 |
| Decision Date | 2001-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630238118132 | K012096 | 000 |
| 00630238090001 | K012096 | 000 |
| 00630238090018 | K012096 | 000 |
| 00630238090025 | K012096 | 000 |
| 00630238090032 | K012096 | 000 |
| 00630238075206 | K012096 | 000 |
| 00630238075213 | K012096 | 000 |
| 00630238075220 | K012096 | 000 |
| 00630238075237 | K012096 | 000 |
| 00630238075244 | K012096 | 000 |
| 00630238117500 | K012096 | 000 |
| 00630238089982 | K012096 | 000 |