The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Mallet, Surgical.
| Device ID | K882349 |
| 510k Number | K882349 |
| Device Name: | MALLET, SURGICAL |
| Classification | Mallet |
| 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 | HXL |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-07 |
| Decision Date | 1988-06-23 |