The following data is part of a premarket notification filed by Elixir Corporation with the FDA for Abc Syringe Infusion Pump, Model 4100.
| Device ID | K072603 |
| 510k Number | K072603 |
| Device Name: | ABC SYRINGE INFUSION PUMP, MODEL 4100 |
| Classification | Pump, Infusion |
| Applicant | ELIXIR CORPORATION 3700 NAMASCO DRIVE SUITE C Suwanee, GA 30024 |
| Contact | William M Vondersmith |
| Correspondent | William M Vondersmith ELIXIR CORPORATION 3700 NAMASCO DRIVE SUITE C Suwanee, GA 30024 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-14 |
| Decision Date | 2008-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863028000311 | K072603 | 000 |
| 00863028000304 | K072603 | 000 |