Well Lead Extraction Bag

Laparoscope, General & Plastic Surgery

WELL LEAD MEDICAL CO., LTD.

The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Well Lead Extraction Bag.

Pre-market Notification Details

Device IDK160801
510k NumberK160801
Device Name:Well Lead Extraction Bag
ClassificationLaparoscope, General & Plastic Surgery
Applicant WELL LEAD MEDICAL CO., LTD. C-4 # JINHU INDUSTRIAL ESTATE, HUALONG, PANYU Guangzhou,  CN 511434
ContactHan Guang Yuan
CorrespondentHan Guang Yuan
WELL LEAD MEDICAL CO., LTD. C-4 # JINHU INDUSTRIAL ESTATE, HUALONG, PANYU Guangzhou,  CN 511434
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-23
Decision Date2016-11-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16944932741192 K160801 000
16936881133746 K160801 000
06936881133756 K160801 000
16936881133760 K160801 000
16936881133777 K160801 000
06936881166488 K160801 000
16936881166492 K160801 000
06944932741157 K160801 000
16944932741178 K160801 000
16944932741185 K160801 000
06936881133725 K160801 000

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