The following data is part of a premarket notification filed by Medicine Lodge, Inc. with the FDA for Mli Soft Tissue Screw & Washer System.
| Device ID | K962194 |
| 510k Number | K962194 |
| Device Name: | MLI SOFT TISSUE SCREW & WASHER SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | MEDICINE LODGE, INC. 819 STRIKER AVE., SUITE 10 Sacramento, CA 95834 -5432 |
| Contact | Brian T Cleary |
| Correspondent | Brian T Cleary MEDICINE LODGE, INC. 819 STRIKER AVE., SUITE 10 Sacramento, CA 95834 -5432 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-07 |
| Decision Date | 1996-07-30 |
| Summary: | summary |