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510(k) K011868

ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS by Debio Tech SA — Product Code LZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2001
Date Received
June 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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