FDA 510(k) Application Details - K974251

Device Classification Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K974251
Device Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant	XYLOS CORPORATION 29 AINSWORTH AVE. EAST BURNSWICK, NJ 08816 US Other 510(k) Applications for this Company
Contact	ERIC FLAM 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	11/13/1997
Decision Date	06/22/1998
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