FDA 510(k) Application Details - K160380

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K160380
Device Name	Colposcope (And Colpomicroscope)
Applicant	Lutech Industries, Inc. 105 Remington Blvd., Suite C Ronkonkoma, NY 11779 US Other 510(k) Applications for this Company
Contact	Ronald Vachula 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	02/10/2016
Decision Date	05/13/2016
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