The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Flieringa-legrand Fixation Ring.
| Device ID | K843195 |
| 510k Number | K843195 |
| Device Name: | VISITEC FLIERINGA-LEGRAND FIXATION RING |
| Classification | Rack, Skiascopic |
| Applicant | VISITEC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HMH |
| CFR Regulation Number | 886.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-14 |
| Decision Date | 1984-10-05 |