Maxcon Two Gallon Chemotherapy Container

Container, Sharps

Ningbo Maxcon Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Maxcon Medical Technology Co., Ltd. with the FDA for Maxcon Two Gallon Chemotherapy Container.

Pre-market Notification Details

Device IDK180983
510k NumberK180983
Device Name:Maxcon Two Gallon Chemotherapy Container
ClassificationContainer, Sharps
Applicant Ningbo Maxcon Medical Technology Co., Ltd. No.30 Dongbei Road/No.228 Dong Xin Road, Dong Qiao Town Ningbo,  CN 315157
ContactYang Song
CorrespondentYang Song
Ningbo Maxcon Medical Technology Co., Ltd. No.30 Dongbei Road/No.228 Dong Xin Road, Dong Qiao Town Ningbo,  CN 315157
Product CodeMMK  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-13
Decision Date2019-01-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840117335783 K180983 000

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