510(k) K970799

ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) by Alexander Mfg. Co. — Product Code LIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1997
Date Received
March 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type