The following data is part of a premarket notification filed by Surgitek with the FDA for Irri-flo Irrigation Delivery System.
| Device ID | K891339 |
| 510k Number | K891339 |
| Device Name: | IRRI-FLO IRRIGATION DELIVERY SYSTEM |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Betty A Lock |
| Correspondent | Betty A Lock SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-06-02 |