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510(k) K250389

XNY Disposable Gastric Calibration Tube by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2025
Date Received
February 11, 2025
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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