The following data is part of a premarket notification filed by Western Advanced Technology, Inc. with the FDA for System 80 Faceplate-in-the-ear #f1.
| Device ID | K822411 |
| 510k Number | K822411 |
| Device Name: | SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 |
| Classification | Syringe, Irrigating (dental) |
| Applicant | WESTERN ADVANCED TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EIB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-10 |
| Decision Date | 1983-07-12 |