510(k) K152350

Device
Regular And Special Umbilical Cord Clamp And Cutter
Applicant
NINGBO FEITE MEDICAL DEVICE CO., LTD
510(k) number
K152350
Product code
NBZ  
Decision
Substantially Equivalent (SESE)
Decision date
2016-06-28
Date received
2015-08-20
Regulation
884.4530
Classification name
Clamp And Cutter, Umbilical
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHARLES SHEN
Address
Tongpenzha, Zhonggongmiao St., Yinzhou District Ningbo CN 315192 315192

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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