The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Vein Graft Ear Scissors.
Device ID | K870756 |
510k Number | K870756 |
Device Name: | VEIN GRAFT EAR SCISSORS |
Classification | Scissors, Ear |
Applicant | TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
Contact | Thomas, Jr |
Correspondent | Thomas, Jr TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
Product Code | JZB |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-26 |
Decision Date | 1987-03-03 |