The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Auto Irrigation System.
| Device ID | K061108 |
| 510k Number | K061108 |
| Device Name: | STRYKER AUTO IRRIGATION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | Stryker 4100 EAST MILHAM AVENUE Kalamazoo, MI 49001 |
| Contact | Valerie Franck |
| Correspondent | Valerie Franck Stryker 4100 EAST MILHAM AVENUE 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 | 2006-04-20 |
| Decision Date | 2007-02-02 |
| Summary: | summary |