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510(k) K161905

Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2016
Date Received
July 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

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