The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Bipol Cable.
Device ID | K863412 |
510k Number | K863412 |
Device Name: | BIPOL CABLE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
Contact | William H Thomas,jr |
Correspondent | William H Thomas,jr TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-03 |
Decision Date | 1986-10-02 |