The following data is part of a premarket notification filed by Saeyang Microtech Co., Ltd with the FDA for Endo A Class.
| Device ID | K123582 |
| 510k Number | K123582 |
| Device Name: | ENDO A CLASS |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | SAEYANG MICROTECH CO., LTD 55 NORTHERN BLVD Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah SAEYANG MICROTECH CO., LTD 55 NORTHERN BLVD Great Neck, NY 11021 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-20 |
| Decision Date | 2013-08-16 |
| Summary: | summary |