FDA 510(k) Application Details - K984266

Device Classification Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K984266
Device Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant	FIDIA PHARMACEUTICAL CORP. 2000 K STREET,N.W SUITE 700 WASHINGTON, DC 20006 US Other 510(k) Applications for this Company
Contact	ROBERTO FIORENTINI 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	11/17/1998
Decision Date	02/10/1999
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