The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Rk Vacuum Fixation Ring System.
| Device ID | K863775 |
| 510k Number | K863775 |
| Device Name: | RK VACUUM FIXATION RING SYSTEM |
| Classification | Ring, Ophthalmic (flieringa) |
| Applicant | AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Contact | Robert Galan |
| Correspondent | Robert Galan AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Product Code | HNH |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-26 |
| Decision Date | 1986-10-20 |