The following data is part of a premarket notification filed by Med-tech Develoment Corp. with the FDA for Fyodorov Radial Keratotomy Marker Set.
| Device ID | K860329 |
| 510k Number | K860329 |
| Device Name: | FYODOROV RADIAL KERATOTOMY MARKER SET |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | MED-TECH DEVELOMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
| Contact | Jose H Bedoya |
| Correspondent | Jose H Bedoya MED-TECH DEVELOMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-29 |
| Decision Date | 1986-02-12 |