FDA 510(k) Application Details - K153128

Device Classification Name	Spatula, Cervical, Cytological   More FDA Info for this Device
510(K) Number	K153128
Device Name	Spatula, Cervical, Cytological
Applicant	KOLPLAST CI SA ESTRADA MUNICIPAL IVA 136. NO 418. BARRIO DA MINA ITUPEVA- SP 13295-000 BR Other 510(k) Applications for this Company
Contact	DANIELA FERACIN 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	10/29/2015
Decision Date	01/13/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review