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510(k) K162340

Stomach Tube by Well Lead Medical Co., Ltd. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2017
Date Received
August 22, 2016
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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