The following data is part of a premarket notification filed by Animas Corp. with the FDA for Ezmanager Plus.
| Device ID | K022394 |
| 510k Number | K022394 |
| Device Name: | EZMANAGER PLUS |
| Classification | Pump, Infusion, Insulin |
| Applicant | ANIMAS CORP. 590 E. LANCASTER AVE. Frazer, PA 19355 |
| Contact | Michael J Andrews |
| Correspondent | Michael J Andrews ANIMAS CORP. 590 E. LANCASTER AVE. Frazer, PA 19355 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-23 |
| Decision Date | 2003-06-05 |
| Summary: | summary |