The following data is part of a premarket notification filed by Mwi, Inc. with the FDA for Excell 22.
| Device ID | K991539 |
| 510k Number | K991539 |
| Device Name: | EXCELL 22 |
| Classification | Counter, Differential Cell |
| Applicant | MWI, INC. 4230 SHILLING WAY Dallas, TX 75237 |
| Contact | Gregory A Witherspoon |
| Correspondent | Gregory A Witherspoon MWI, INC. 4230 SHILLING WAY Dallas, TX 75237 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-07-01 |
| Summary: | summary |