The following data is part of a premarket notification filed by Osada Electric Co., Ltd. with the FDA for Osada Endex.
| Device ID | K904742 |
| 510k Number | K904742 |
| Device Name: | OSADA ENDEX |
| Classification | Locator, Root Apex |
| Applicant | OSADA ELECTRIC CO., LTD. 8242 W. 3RD ST., STE. 150 Los Angeles, CA 90048 |
| Contact | Yoshino C Hara |
| Correspondent | Yoshino C Hara OSADA ELECTRIC CO., LTD. 8242 W. 3RD ST., STE. 150 Los Angeles, CA 90048 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-18 |
| Decision Date | 1990-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582227432711 | K904742 | 000 |
| 04582227425249 | K904742 | 000 |
| 04582227408143 | K904742 | 000 |
| 04582227343567 | K904742 | 000 |
| 04580406870682 | K904742 | 000 |
| 04580406860416 | K904742 | 000 |
| 04580406860348 | K904742 | 000 |
| 04580406860133 | K904742 | 000 |