510(k) K882830

INFUSION PUMP by Pemlab Corp. — Product Code LZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1988
Date Received
July 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Analytical Sampling
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type