Sharps Container

Container, Sharps

Zhejiang Gongdong Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Zhejiang Gongdong Medical Technology Co., Ltd with the FDA for Sharps Container.

Pre-market Notification Details

Device IDK201523
510k NumberK201523
Device Name:Sharps Container
ClassificationContainer, Sharps
Applicant Zhejiang Gongdong Medical Technology Co., Ltd No.10, Beiyuan Avenue, Huangyan Taizhou,  CN 318020
ContactWeifeng Zhong
CorrespondentIvy Wang
Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai,  CN 200122
Product CodeMMK  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-11-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16947462492381 K201523 000
06947462492353 K201523 000
16947462492398 K201523 000
16947462492374 K201523 000
16947462492367 K201523 000
16947462492343 K201523 000

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