FDA 510(k) Application Details - K971918

Device Classification Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K971918
Device Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant	AMERX HEALTH CARE CORP. 1150 CLEVELAND ST. SUITE 410 CLEARWATER, FL 34615 US Other 510(k) Applications for this Company
Contact	RON MADDIX Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MGQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/1997
Decision Date	08/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review