The following data is part of a premarket notification filed by Millennium Medical Technologies, Inc. with the FDA for Wristore Fixator.
| Device ID | K012294 |
| 510k Number | K012294 |
| Device Name: | WRISTORE FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | MILLENNIUM MEDICAL TECHNOLOGIES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf MILLENNIUM MEDICAL TECHNOLOGIES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-20 |
| Decision Date | 2002-03-04 |
| Summary: | summary |