FDA 510(k) Application Details - K122105

Device Classification Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene   More FDA Info for this Device
510(K) Number	K122105
Device Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant	SOLINAS MEDICAL INC 443 COSTA MESA TERRACE SUNNY VALE, CA 94089 US Other 510(k) Applications for this Company
Contact	JAMES HONG 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	07/17/2012
Decision Date	12/07/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review