FDA 510(k) Application Details - K152350

Device Classification Name	Clamp And Cutter, Umbilical   More FDA Info for this Device
510(K) Number	K152350
Device Name	Clamp And Cutter, Umbilical
Applicant	NINGBO FEITE MEDICAL DEVICE CO., LTD TONGPENZHA, ZHONGGONGMIAO STREET, YINZHOU DISTRICT NINGBO 315192 CN Other 510(k) Applications for this Company
Contact	CHARLES SHEN Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	NBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2015
Decision Date	06/28/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review