FDA 510(k) Application Details - K000519

Device Classification Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K000519
Device Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant	BRENNEN MEDICAL, INC. 1290 HAMMOND RD. ST. PAUL, MN 55110 US Other 510(k) Applications for this Company
Contact	PHIL LAWIN 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	02/16/2000
Decision Date	05/01/2000
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