FDA 510(k) Application Details - K983454

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K983454
Device Name	Pump, Infusion, Elastomeric
Applicant	BREG, INC. 2611 COMMERCE WAY VISTA, CA 92083 US Other 510(k) Applications for this Company
Contact	KATHLEEN BARBER Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/1998
Decision Date	12/16/1998
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