FDA 510(k) Application Details - K190187

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K190187
Device Name	Colposcope (And Colpomicroscope)
Applicant	Illumigyn Ltd. Communication Center Neve Ilan 9085000 IL Other 510(k) Applications for this Company
Contact	Lior Greenstein Other 510(k) Applications for this Contact
Regulation Number	884.1630   More FDA Info for this Regulation Number
Classification Product Code	HEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2019
Decision Date	05/08/2019
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