FDA 510(k) Application Details - K130852

Device Classification Name	More FDA Info for this Device
510(K) Number	K130852
Device Name	AVANCE« FOAM ABDOMINAL DRESSING KIT
Applicant	MOLNLYCKE HEALTHCARE 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS, GA 30092 US Other 510(k) Applications for this Company
Contact	ANGELA L BUNN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2013
Decision Date	04/14/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review