510(k) K981776

ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X by Alexander Mfg. Co. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1998
Date Received
May 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type