FDA 510(k) Application Details - K011868

Device Classification Name	Pump, Infusion, Enteral   More FDA Info for this Device
510(K) Number	K011868
Device Name	Pump, Infusion, Enteral
Applicant	DEBIOTECH S.A. 16787 BERNARDO CENTER DR. SUITE A-1 SAN DIEGO, CA 92128-2504 US Other 510(k) Applications for this Company
Contact	SEAN CURRY Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	LZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2001
Decision Date	09/04/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review