The following data is part of a premarket notification filed by Benlan, Inc. with the FDA for Med-rx Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001.
| Device ID | K010607 |
| 510k Number | K010607 |
| Device Name: | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 |
| Classification | System, Irrigation, Urological |
| Applicant | BENLAN, INC. 2760 BRIGHTON RD. Oakville, Ontario, CA L6h 5t4 |
| Contact | Bill Lim |
| Correspondent | Bill Lim BENLAN, INC. 2760 BRIGHTON RD. Oakville, Ontario, CA L6h 5t4 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-01 |
| Decision Date | 2001-11-28 |