The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for 25mm Peyman Wide Field Yag Laser Lens.
| Device ID | K871450 |
| 510k Number | K871450 |
| Device Name: | 25MM PEYMAN WIDE FIELD YAG LASER 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 | 1987-04-13 |
| Decision Date | 1987-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630238118613 | K871450 | 000 |
| 00630238118606 | K871450 | 000 |
| 00630238109703 | K871450 | 000 |
| 00630238088435 | K871450 | 000 |
| 00630238088367 | K871450 | 000 |
| 00630238007344 | K871450 | 000 |