FDA 510(k) Application Details - K061306

Device Classification Name	Colposcope (And Colpomicroscope)   More FDA Info for this Device
510(K) Number	K061306
Device Name	Colposcope (And Colpomicroscope)
Applicant	GYNEX CORP. 2789 152ND AVE., NE REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	KAREN CARDIFF 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	05/10/2006
Decision Date	08/07/2006
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