FDA 510(k) Application Details - K083354

Device Classification Name	Sealant, Microbial   More FDA Info for this Device
510(K) Number	K083354
Device Name	Sealant, Microbial
Applicant	ADHEZION BIOMEDICAL 506 PINE MOUNTAIN RD HUDSON, NC 28638 US Other 510(k) Applications for this Company
Contact	RICHARD JONES Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	NZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2008
Decision Date	07/20/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review