The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Surefuser Ambulatory Infusion Pump.
| Device ID | K051828 |
| 510k Number | K051828 |
| Device Name: | NIPRO SUREFUSER AMBULATORY INFUSION PUMP |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | NIPRO MEDICAL CORPORATION 1384 COPPERFIELD COURT Lexington, KY 40514 |
| Contact | Kaelyn Hadley |
| Correspondent | Kaelyn Hadley NIPRO MEDICAL CORPORATION 1384 COPPERFIELD COURT Lexington, KY 40514 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-06 |
| Decision Date | 2005-12-15 |
| Summary: | summary |