The following data is part of a premarket notification filed by Applied Medical with the FDA for Suction Irrigator.
| Device ID | K003443 |
| 510k Number | K003443 |
| Device Name: | SUCTION IRRIGATOR |
| Classification | System, Evacuator, Fluid |
| Applicant | APPLIED MEDICAL 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani APPLIED MEDICAL 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | FHF |
| CFR Regulation Number | 876.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-06 |
| Decision Date | 2001-02-01 |