The following data is part of a premarket notification filed by Wickimed (huizhou) Medical Equipment Manufacturing Co., Ltd. with the FDA for Suction Irrigation Set.
Device ID | K172794 |
510k Number | K172794 |
Device Name: | Suction Irrigation Set |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Tang Jiao Xing 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 Xing 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 | 2017-09-15 |
Decision Date | 2017-11-29 |
Summary: | summary |