The following data is part of a premarket notification filed by Tdak Medical, Inc with the FDA for Ek Delivery Device.
| Device ID | K121579 |
| 510k Number | K121579 |
| Device Name: | EK DELIVERY DEVICE |
| Classification | Graft Insertion Instrument For Endothelial Keratoplasty |
| Applicant | TDAK MEDICAL, INC 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland TDAK MEDICAL, INC 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | OTZ |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-30 |
| Decision Date | 2012-10-03 |
| Summary: | summary |