FDA 510(k) Application Details - K062795

Device Classification Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K062795
Device Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant	ACCESS PHARMACEUTICALS, INC 2600 STEMMONS FREEWAY SUITE 176 DALLAS, TX 75207 US Other 510(k) Applications for this Company
Contact	DAVID NOWOTNIK, PH.D. 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	09/18/2006
Decision Date	12/11/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review