FDA 510(k) Application Details - K041094

Device Classification Name	Cannula, Manipulator/Injector, Uterine   More FDA Info for this Device
510(K) Number	K041094
Device Name	Cannula, Manipulator/Injector, Uterine
Applicant	BIOTEQUE AMERICA, INC. 340 EAST MAPLE AVE., #204-C LANGHORNE, PA 19047 US Other 510(k) Applications for this Company
Contact	DENIS DORSEY Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2004
Decision Date	06/17/2004
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	Y
Expedited Review