FDA 510(k) Application Details - K083721

Device Classification Name	Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K083721
Device Name	Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic
Applicant	RIVER'S EDGE PHARMACEUTICALS, LLC 2445 SOUTH ALSTON AVE. DURHAM, NC 27713 US Other 510(k) Applications for this Company
Contact	SANDRA R KIRCUS Other 510(k) Applications for this Contact
Regulation Number	878.4022   More FDA Info for this Regulation Number
Classification Product Code	NAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2008
Decision Date	01/08/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review