FDA 510(k) Application Details - K850535

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K850535
Device Name	Dressing, Wound, Drug
Applicant	MITRAL MEDICAL LTD. 4070 YOUNGFIELD ST. WHEAT RIDGE, CO US Other 510(k) Applications for this Company
Contact	RENA E TODD Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/1985
Decision Date	06/05/1985
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	-
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review