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 |