FDA 510(k) Application Details - K082208

Device Classification Name	Dressing,Wound,Hydrophilic   More FDA Info for this Device
510(K) Number	K082208
Device Name	Dressing,Wound,Hydrophilic
Applicant	SCIVOLUTIONS, INC. 962 ALLEGRO LANE APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ARTHUR WARD Other 510(k) Applications for this Contact
Regulation Number	878.4018   More FDA Info for this Regulation Number
Classification Product Code	NAC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2008
Decision Date	12/01/2008
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