FDA 510(k) Application Details - K091769

Device Classification Name	Barrier,Std,Oral Sex   More FDA Info for this Device
510(K) Number	K091769
Device Name	Barrier,Std,Oral Sex
Applicant	LINE ONE LABORATORIES, INC. PO BOX 12139 DURHAM, NC 27709 US Other 510(k) Applications for this Company
Contact	ELI J CARTER Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	MSC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2009
Decision Date	02/05/2010
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