510(k) K202357

Nutricare Clear-ISOSAF Nasogastric Feeding Tube by Three Circles Consulting Limited — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2020
Date Received
August 19, 2020
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.