The following data is part of a premarket notification filed by Centurion Medical Products Corporation with the FDA for Centurion Pressure Injectable Extension Set.
| Device ID | K103562 |
| 510k Number | K103562 |
| Device Name: | CENTURION PRESSURE INJECTABLE EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | CENTURION MEDICAL PRODUCTS CORPORATION 100 CENTURION WAY Williamston, MI 48895 |
| Contact | Matthew K Price |
| Correspondent | Matthew K Price CENTURION MEDICAL PRODUCTS CORPORATION 100 CENTURION WAY Williamston, MI 48895 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-06-23 |
| Summary: | summary |