The following data is part of a premarket notification filed by Wickimed (huizhou) Medical Equipment Manufacturing Co.,ltd. with the FDA for Trocar.
Device ID | K172038 |
510k Number | K172038 |
Device Name: | Trocar |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Tang Jiao Wang Street, Lilin Town Zhongkai Hi-Tech Zone Huizhou, CN 516000 |
Contact | Haobin Li |
Correspondent | Haobin Li WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Tang Jiao Wang Street, Lilin Town Zhongkai Hi-Tech Zone Huizhou, CN 516000 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-05 |
Decision Date | 2017-10-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TROCAR 86526529 4812059 Live/Registered |
FERADYNE OUTDOORS, LLC 2015-02-06 |