The following data is part of a premarket notification filed by Mps Acacia with the FDA for Mps Acacia Power Injectable Infusion Set.
| Device ID | K090809 |
| 510k Number | K090809 |
| Device Name: | MPS ACACIA POWER INJECTABLE INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MPS ACACIA 785 CHALLENGER ST. Brea, CA 92821 |
| Contact | Fergie Ferguson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816513023548 | K090809 | 000 |
| 00816513022664 | K090809 | 000 |
| 00816513022633 | K090809 | 000 |
| 00816513022619 | K090809 | 000 |
| 10816513024535 | K090809 | 000 |
| 10810080610207 | K090809 | 000 |