510(k) K972780

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 by Alexander Mfg. Co. — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1997
Date Received
July 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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