The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Instrument Guard Capsule.
| Device ID | K831588 |
| 510k Number | K831588 |
| Device Name: | INSTRUMENT GUARD CAPSULE |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-17 |
| Decision Date | 1983-06-15 |