FDA 510(k) Application Details - K141057

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K141057
Device Name	Spatula, Cervical, Cytological
Applicant	NINGBO HLS MEDICAL PRODUCTS CO., LTD 3500 SOUTH DUPONT HIGHWAY DOVER, DE 19901 US Other 510(k) Applications for this Company
Contact	LEON LU Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2014
Decision Date	05/14/2015
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