The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Painpump Pca.
| Device ID | K003543 |
| 510k Number | K003543 |
| Device Name: | STRYKER PAINPUMP PCA |
| 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 | 2000-11-17 |
| Decision Date | 2001-06-05 |