FDA 510(k) Application Details - K031785

Device Classification Name	Pericardial Patch To Facilitate Revision Surgeries   More FDA Info for this Device
510(K) Number	K031785
Device Name	Pericardial Patch To Facilitate Revision Surgeries
Applicant	MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. 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	OMH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2003
Decision Date	09/04/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review