FDA 510(k) Application Details - DEN090011

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN090011
Device Name	HEM-AVERT PERIANAL STABILIZER
Applicant	PLEXUS BIOMEDICAL INC. 70 CLAY STREET SUITE 2 OAKLAND, TN 38060 US Other 510(k) Applications for this Company
Contact	DAVID BLURTON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OOA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2009
Decision Date	01/13/2011
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review