The following data is part of a premarket notification filed by Wickimed (huizhou) Medical Equipment Manufacturing Co.,ltd. with the FDA for Veress Needle.
Device ID | K172120 |
510k Number | K172120 |
Device Name: | Veress Needle |
Classification | Pneumoperitoneum Needle |
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 | FHO |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-13 |
Decision Date | 2017-09-14 |
Summary: | summary |