FDA 510(k) Application Details - K063401

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K063401
Device Name	Condom
Applicant	MEDTECH PRODUCTS LTD. 5876 155TH AVE. S.E. BELLEVUE, WA 98006 US Other 510(k) Applications for this Company
Contact	RAVI REDDY Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	HIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2006
Decision Date	03/26/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review