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510(k) K191844

Fidmi Low Profile Enteral Feeding Device by Fidmi Medical, Ltd. — Product Code KGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2019
Date Received
July 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Gastro-Enterostomy
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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