Suction Irrigation Set

Laparoscope, General & Plastic Surgery

WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.

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.

Pre-market Notification Details

Device IDK172794
510k NumberK172794
Device Name:Suction Irrigation Set
ClassificationLaparoscope, 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
ContactHaobin Li
CorrespondentHaobin Li
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Tang Jiao Xing Wang Street LiLin Town, ZhongKai Hi-Tech Zone Huizhou,  CN 516000
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-15
Decision Date2017-11-29
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.