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 |