FDA 510(k) Application Details - K973133

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K973133
Device Name	Pump, Infusion
Applicant	BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 TUCSON, AZ 85706 US Other 510(k) Applications for this Company
Contact	STEVE BOLLINGER Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	FRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/1997
Decision Date	09/12/1997
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review