FDA 510(k) Application Details - K101097

Device Classification Name	More FDA Info for this Device
510(K) Number	K101097
Device Name	CALGAESEAL MODEL: CAS
Applicant	BZ MEDICAL INC 6611 SW BURLINGAME AVE PORTLAND, OR 97239 US Other 510(k) Applications for this Company
Contact	BYRON ZAHLER 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	04/20/2010
Decision Date	09/22/2010
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