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510(k) K160287

Rapid Barostat Bag (RBB) Pump and Catheter by Mui Scientific — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2017
Date Received
February 3, 2016
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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  • K823701 — MOTILITY CATHETERS (February 15, 1983)

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