FDA 510(k) Application Details - K051594

Device Classification Name	Culdoscope (And Accessories)   More FDA Info for this Device
510(K) Number	K051594
Device Name	Culdoscope (And Accessories)
Applicant	GYNETECH PTY. LTD. 4545 CREEK ROAD CINCINNATI, OH 45242-2839 US Other 510(k) Applications for this Company
Contact	DENNIS HAHN Other 510(k) Applications for this Contact
Regulation Number	884.1640   More FDA Info for this Regulation Number
Classification Product Code	HEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2005
Decision Date	09/02/2005
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