The following data is part of a premarket notification filed by Osada Electric Co., Ltd. with the FDA for Osada Enac.
| Device ID | K844250 |
| 510k Number | K844250 |
| Device Name: | OSADA ENAC |
| Classification | Scaler, Ultrasonic |
| Applicant | OSADA ELECTRIC CO., LTD. 8242 W. 3RD ST., STE. 150 Los Angeles, CA 90048 |
| Contact | Charlene Hara |
| Correspondent | Charlene Hara OSADA ELECTRIC CO., LTD. 8242 W. 3RD ST., STE. 150 Los Angeles, CA 90048 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-02 |
| Decision Date | 1985-01-23 |