The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Tanne Corneal Cutting Block.
| Device ID | K871646 |
| 510k Number | K871646 |
| Device Name: | TANNE CORNEAL CUTTING BLOCK |
| Classification | Punch, Corneo-scleral |
| 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 | HNJ |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-05-18 |