FDA 510(k) Application Details - K963228

Device Classification Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K963228
Device Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant	ORPHAN MEDICAL, INC. 13911 RIDGEDALE DR., SUITE 475 MINNETONKA, MN 55305 US Other 510(k) Applications for this Company
Contact	DAYTON T REARDAN 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	08/19/1996
Decision Date	12/18/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review