The following data is part of a premarket notification filed by Applied Medical with the FDA for Epix Irrigation Pump, Epix Suction Irrigation Tubing Set.
| Device ID | K122619 |
| 510k Number | K122619 |
| Device Name: | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | APPLIED MEDICAL 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Jessica Cho |
| Correspondent | Jessica Cho APPLIED MEDICAL 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-28 |
| Decision Date | 2012-10-02 |
| Summary: | summary |