The following data is part of a premarket notification filed by Saeyang Microtech Co Ltd with the FDA for Ki-20.
| Device ID | K141482 |
| 510k Number | K141482 |
| Device Name: | KI-20 |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | SAEYANG MICROTECH CO LTD 2651 E.CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung SAEYANG MICROTECH CO LTD 2651 E.CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-04 |
| Decision Date | 2015-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809394970881 | K141482 | 000 |