The following data is part of a premarket notification filed by Nortech Laboratories, Inc. with the FDA for Irriclear Ear Irrigation Syringe.
| Device ID | K903759 |
| 510k Number | K903759 |
| Device Name: | IRRICLEAR EAR IRRIGATION SYRINGE |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | NORTECH LABORATORIES, INC. 1205 ARROWHEAD DR. Dubuque, IA 52001 |
| Contact | Michael Zeman |
| Correspondent | Michael Zeman NORTECH LABORATORIES, INC. 1205 ARROWHEAD DR. Dubuque, IA 52001 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1990-10-26 |