The following data is part of a premarket notification filed by Level 1 Technologies, Inc. with the FDA for Level 1 Ir-600 Normothermic Irrigating Set.
| Device ID | K873435 |
| 510k Number | K873435 |
| Device Name: | LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET |
| Classification | Catheter, Urological |
| Applicant | LEVEL 1 TECHNOLOGIES, INC. 29 ALDRIN RD. Plymouth, MA 02360 |
| Contact | Gary D Tureski |
| Correspondent | Gary D Tureski LEVEL 1 TECHNOLOGIES, INC. 29 ALDRIN RD. Plymouth, MA 02360 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-26 |
| Decision Date | 1987-10-05 |