The following data is part of a premarket notification filed by Beijing Honkon Technologies Co., Ltd with the FDA for Multifunctional Series.
Device ID | K131859 |
510k Number | K131859 |
Device Name: | MULTIFUNCTIONAL SERIES |
Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
Applicant | BEIJING HONKON TECHNOLOGIES CO., LTD P.O. BOX 120-119 Shanghai, CN 200030 |
Contact | Diana Hong |
Correspondent | Diana Hong BEIJING HONKON TECHNOLOGIES CO., LTD P.O. BOX 120-119 Shanghai, CN 200030 |
Product Code | ONF |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-24 |
Decision Date | 2013-10-18 |
Summary: | summary |