FDA 510(k) Application Details - K143119

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K143119
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	Ron 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	10/30/2014
Decision Date	12/18/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review