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510(k) K213356

Entuit PEG, Entuit PEGJ by Wilson-Cook Medical, Inc. — Product Code PIF

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
January 20, 2022
Date Received
October 12, 2021
Clearance Type
Special
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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