FDA 510(k) Application Details - K090637

Device Classification Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene   More FDA Info for this Device
510(K) Number	K090637
Device Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant	MAST BIOSURGERY USA INC. 6749 TOP GUN ST., SUITE C SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	KENNETH K KLEINHENZ Other 510(k) Applications for this Contact
Regulation Number	870.3470   More FDA Info for this Regulation Number
Classification Product Code	DXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2009
Decision Date	01/07/2010
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review