The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Kratz Nova-sert.
| Device ID | K871440 |
| 510k Number | K871440 |
| Device Name: | KRATZ NOVA-SERT |
| Classification | Lens, Guide, Intraocular |
| Applicant | COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue, WA 98008 |
| Contact | Tom Trotter |
| Correspondent | Tom Trotter COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue, WA 98008 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-13 |
| Decision Date | 1987-05-07 |