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510(k) K120524

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM by Mui Scientific — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2012
Date Received
February 22, 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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