The following data is part of a premarket notification filed by Omni-glow, Inc. with the FDA for Infusion Pump & Iv Sets #4000.
| Device ID | K832755 |
| 510k Number | K832755 |
| Device Name: | INFUSION PUMP & IV SETS #4000 |
| Classification | Pump, Infusion |
| Applicant | OMNI-GLOW, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-16 |
| Decision Date | 1983-11-03 |