The following data is part of a premarket notification filed by Animas Corp. with the FDA for Animus Ezserter Infusion Set Inserter.
| Device ID | K021700 |
| 510k Number | K021700 |
| Device Name: | ANIMUS EZSERTER INFUSION SET INSERTER |
| Classification | Introducer, Syringe Needle |
| Applicant | ANIMAS CORP. 590 E. LANCASTER AVE. Frazer, PA 19355 |
| Contact | Richard Michelin |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-05-23 |
| Decision Date | 2002-06-04 |
| Summary: | summary |