FDA 510(k) Application Details - K090100

Device Classification Name	More FDA Info for this Device
510(K) Number	K090100
Device Name	SOFTSEAL-STF
Applicant	CHITOGEN, INC. 7255 OHMS LANE MINNEAPOLIS, MN 55439 US Other 510(k) Applications for this Company
Contact	JANNA BEREUTER 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	01/15/2009
Decision Date	03/11/2009
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