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510(k) K190923

Salem Sump Dual Lumen Stomach Tube with ENFit Connection by Cardinalhealth — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2019
Date Received
April 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Tubes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To facilitate enteral specific connections.

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