The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Hole Chamfering Device.
| Device ID | K841298 |
| 510k Number | K841298 |
| Device Name: | HOLE CHAMFERING DEVICE |
| Classification | Bur, Surgical, General & Plastic Surgery |
| Applicant | TECHMEDICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-30 |
| Decision Date | 1984-04-25 |