FDA 510(k) Application Details - K122973

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K122973
Device Name	Colposcope (And Colpomicroscope)
Applicant	MEDGYN PRODUCTS, INC. 12 SOUTH FIRST STREE 12TH FLOOR SAN JOSE, CA 95113 US Other 510(k) Applications for this Company
Contact	STEPHANIE BLAIR 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	09/26/2012
Decision Date	06/12/2013
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