The following data is part of a premarket notification filed by Acta Medical Llc with the FDA for Empty Eva Solution Container Empty Eva Dual Chamber Solution Container.
| Device ID | K121161 |
| 510k Number | K121161 |
| Device Name: | EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER |
| Classification | Container, I.v. |
| Applicant | ACTA MEDICAL LLC 929 ARBOR DOWNS SR Plano, TX 75023 |
| Contact | Aaron Compton |
| Correspondent | Aaron Compton ACTA MEDICAL LLC 929 ARBOR DOWNS SR Plano, TX 75023 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-17 |
| Decision Date | 2012-07-13 |
| Summary: | summary |