510(k) K011587

SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP by Entracon Corp. — Product Code LZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2001
Date Received
May 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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