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510(k) K190084

McLean-Ring Enteral Feeding Tube Set by Cook Incorporated — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2019
Date Received
January 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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