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 |