The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Modification To Stryker Painpump.
| Device ID | K031249 |
| 510k Number | K031249 |
| Device Name: | MODIFICATION TO STRYKER PAINPUMP |
| Classification | Pump, Infusion |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Nicole Petty |
| Correspondent | Nicole Petty 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 | 2003-04-18 |
| Decision Date | 2003-07-21 |
| Summary: | summary |