FDA 510(k) Application Details - K072890

Device Classification Name	More FDA Info for this Device
510(K) Number	K072890
Device Name	STASILON FR
Applicant	ENTEGRION, INC. 79 TW ALEXANDER DRIVE SUITE 20 4401 RESEARCH COMMONS RESEARCH TRIANGLE PARK, NC 27709 US Other 510(k) Applications for this Company
Contact	E.S. ESKRIDGE, JR. Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2007
Decision Date	12/10/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review