The following data is part of a premarket notification filed by Mps Acacia with the FDA for Mps Acacia Medflo Infusion (li) And Mps Acacia Medflo Infusion (li) Keep Vein Open (kvo) Elastomeric Pumps.
| Device ID | K011117 |
| 510k Number | K011117 |
| Device Name: | MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | MPS ACACIA 499 NIBUS ST., SUITE E Brea, CA 92821 |
| Contact | Fergie F Ferguson |
| Correspondent | Fergie F Ferguson MPS ACACIA 499 NIBUS ST., SUITE E Brea, CA 92821 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-12 |
| Decision Date | 2001-07-09 |