The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Discmonitor.
| Device ID | K050753 |
| 510k Number | K050753 |
| Device Name: | STRYKER DISCMONITOR |
| Classification | Syringe, Piston |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Jean W Sheppard |
| Correspondent | Jean W Sheppard STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-23 |
| Decision Date | 2005-05-18 |
| Summary: | summary |