The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Painpump2.
| Device ID | K043466 |
| 510k Number | K043466 |
| Device Name: | PAINPUMP2 |
| Classification | Pump, Infusion |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Jennifer Mars |
| Correspondent | Jennifer Mars STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-15 |
| Decision Date | 2005-05-10 |
| Summary: | summary |