The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Bipolator 50.
| Device ID | K874779 |
| 510k Number | K874779 |
| Device Name: | BIPOLATOR 50 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TREACE MEDICAL, INC. ATTORNEY AT LAW 22 NORTH SECOND ST., STE. 400 Memphis, TN 38102 |
| Contact | William Thomas |
| Correspondent | William Thomas TREACE MEDICAL, INC. ATTORNEY AT LAW 22 NORTH SECOND ST., STE. 400 Memphis, TN 38102 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-19 |
| Decision Date | 1988-01-29 |