The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Hoskins-barkan Goniotomy Lens 9mm.
| Device ID | K875114 |
| 510k Number | K875114 |
| Device Name: | HOSKINS-BARKAN GONIOTOMY LENS 9MM |
| 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 | 1987-12-14 |
| Decision Date | 1988-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630238084802 | K875114 | 000 |
| 00630238008334 | K875114 | 000 |
| 00630238007993 | K875114 | 000 |