The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Irrijet.
| Device ID | K810209 |
| 510k Number | K810209 |
| Device Name: | IRRIJET |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | ACKRAD LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-26 |
| Decision Date | 1981-02-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IRRIJET 73434285 1294104 Live/Registered |
Ackrad Laboratories, Inc. 1983-07-12 |