The following data is part of a premarket notification filed by Corneagen, Inc with the FDA for Endoserter-pl.
| Device ID | K203586 |
| 510k Number | K203586 |
| Device Name: | EndoSerter-PL |
| Classification | Graft Insertion Instrument For Endothelial Keratoplasty |
| Applicant | CorneaGen, Inc 101 N. Chestnut Street, Suite 303 Winston Salem, NC 27101 |
| Contact | Tom Miller |
| Correspondent | Omid Kodai Khodai Consulting, Inc. 23 Bellflower Lake Forest, CA 92630 |
| Product Code | OTZ |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-08 |
| Decision Date | 2022-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855934007485 | K203586 | 000 |