The following data is part of a premarket notification filed by Mps Acacia with the FDA for Mps Acacia Safeguard Huber Device.
| Device ID | K032934 |
| 510k Number | K032934 |
| Device Name: | MPS ACACIA SAFEGUARD HUBER DEVICE |
| Classification | Set, Administration, Intravascular |
| Applicant | MPS ACACIA 499 NIBUS ST., SUITE E Brea, CA 92821 |
| Contact | Fergie F Ferguson |
| Correspondent | Alfredo J Quattrone, Ph.d., D.a.b.t CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 942732 (MS-357) Sacramento, CA 94234 -7320 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2003-11-13 |
| Summary: | summary |