FDA 510(k) Application Details - K012262

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K012262
Device Name	Accessories, Pump, Infusion
Applicant	NATIONAL CUSTOM ENT., INC. 1133 EAST CLIFF RD. BURNSVILLE, MN 55337 US Other 510(k) Applications for this Company
Contact	DON PELLETIER Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2001
Decision Date	09/12/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review