FDA 510(k) Application Details - K100595

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K100595
Device Name	Colposcope (And Colpomicroscope)
Applicant	Ecleris USA 12225 WORLD TRADE DRIVE SUITE K SAN DIEGO, CA 92128 US Other 510(k) Applications for this Company
Contact	RAYMOND J KELLY IV 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	03/02/2010
Decision Date	07/09/2010
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