The following data is part of a premarket notification filed by Acta Medical Llc with the FDA for Intravascular Administration Set.
| Device ID | K121803 |
| 510k Number | K121803 |
| Device Name: | INTRAVASCULAR ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | ACTA MEDICAL LLC 15 MINNEAKONING RD. SUITE 203 Flemington, NJ 08822 |
| Contact | John Brewer |
| Correspondent | John Brewer ACTA MEDICAL LLC 15 MINNEAKONING RD. SUITE 203 Flemington, NJ 08822 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-19 |
| Decision Date | 2012-12-19 |
| Summary: | summary |