The following data is part of a premarket notification filed by Ilooda Co., Ltd. with the FDA for Secret Rf.
Device ID | K170325 |
510k Number | K170325 |
Device Name: | SECRET RF |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Ilooda Co., Ltd. 120, Jangan-ro 458 Beon-gil Jangan-Gu Suwon-si, KR 100-85816200 |
Contact | Yun Jung Ha |
Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-02 |
Decision Date | 2017-06-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800023200195 | K170325 | 000 |
08800023200188 | K170325 | 000 |
08800023200171 | K170325 | 000 |
08800016903287 | K170325 | 000 |
08800016903331 | K170325 | 000 |
08800016903300 | K170325 | 000 |
08800016903294 | K170325 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SECRET RF 88325107 5924725 Live/Registered |
ILOODA Co., Ltd. 2019-03-04 |