FDA 510(k) Application Details - K092433

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K092433
Device Name	Colposcope (And Colpomicroscope)
Applicant	FORTH PHOTONICS HELLAS SA 690 CANTON ST, SUITE 302 WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	JUAN CARLOS SERNA 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	08/07/2009
Decision Date	03/10/2011
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