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510(k) K122294

PRESSURIZED INFUSION PUMP by Mui Scientific — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2012
Date Received
July 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

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