The following data is part of a premarket notification filed by Union Medical Engeneering Co., Ltd. with the FDA for Um-l20/ Um-l30.
| Device ID | K982860 |
| 510k Number | K982860 |
| Device Name: | UM-L20/ UM-L30 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | UNION MEDICAL ENGENEERING CO., LTD. 8930 S.W. 68TH COURT #H3 Miami, FL 33156 |
| Contact | Annie Valez |
| Correspondent | Annie Valez UNION MEDICAL ENGENEERING CO., LTD. 8930 S.W. 68TH COURT #H3 Miami, FL 33156 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-13 |
| Decision Date | 1999-08-13 |