The following data is part of a premarket notification filed by Lakong Medical Device Company, Ltd with the FDA for Lakong Ultrasonic Scaler.
| Device ID | K103498 |
| 510k Number | K103498 |
| Device Name: | LAKONG ULTRASONIC SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | LAKONG MEDICAL DEVICE COMPANY, LTD 18525 E. GALE AVE. City Of Industry, CA 91748 |
| Contact | Danny Wang |
| Correspondent | Danny Wang LAKONG MEDICAL DEVICE COMPANY, LTD 18525 E. GALE AVE. City Of Industry, CA 91748 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-29 |
| Decision Date | 2011-03-31 |