The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Motorized Micro Multileaf Collimator.
| Device ID | K000349 |
| 510k Number | K000349 |
| Device Name: | MOTORIZED MICRO MULTILEAF COLLIMATOR |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Kristyn R Kelley |
| Correspondent | Kristyn R Kelley STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-03 |
| Decision Date | 2000-05-03 |