The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Wise Iridotomy-spincterotomy Lens.
| Device ID | K861648 |
| 510k Number | K861648 |
| Device Name: | WISE IRIDOTOMY-SPINCTEROTOMY 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 | 1986-04-30 |
| Decision Date | 1986-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630238007597 | K861648 | 000 |