The following data is part of a premarket notification filed by Osada Electric Co., Ltd. with the FDA for Add Line Devices(parts) Electric Handpiece Systems.
| Device ID | K935443 |
| 510k Number | K935443 |
| Device Name: | ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS |
| Classification | Saw, Bone, Ac-powered |
| Applicant | OSADA ELECTRIC CO., LTD. 8242 W. 3RD ST., STE. 150 Los Angeles, CA 90048 |
| Contact | Yoshino Charlene Hara |
| Correspondent | Yoshino Charlene Hara OSADA ELECTRIC CO., LTD. 8242 W. 3RD ST., STE. 150 Los Angeles, CA 90048 |
| Product Code | DZH |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-12 |
| Decision Date | 1994-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582227427458 | K935443 | 000 |
| 04582227341464 | K935443 | 000 |
| 04582227341457 | K935443 | 000 |