FDA 510(k) Application Details - K112864

Device Classification Name	More FDA Info for this Device
510(K) Number	K112864
Device Name	SOFTSEAL-C
Applicant	CHITOGEN, INC. 7255 OHMS LANE MINNEAPOLIS, MN 55439 US Other 510(k) Applications for this Company
Contact	JAMES F DRAKE 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	09/30/2011
Decision Date	08/02/2012
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