The following data is part of a premarket notification filed by Promepla with the FDA for Promepla Intravascular Administration Set And Extension Set.
| Device ID | K071421 |
| 510k Number | K071421 |
| Device Name: | PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | PROMEPLA 5600 WISCONSIN AVENUE SUITE 509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler PROMEPLA 5600 WISCONSIN AVENUE SUITE 509 Chevy Chase, MD 20815 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-22 |
| Decision Date | 2007-10-04 |
| Summary: | summary |