The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Abraham Iridectomy Lens (yag Laser).
| Device ID | K862713 |
| 510k Number | K862713 |
| Device Name: | ABRAHAM IRIDECTOMY LENS (YAG LASER) |
| Classification | Prism, Gonioscopic |
| 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 | HKS |
| CFR Regulation Number | 886.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-16 |
| Decision Date | 1986-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630238071369 | K862713 | 000 |
| 00630238007290 | K862713 | 000 |