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510(k) K172960

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use by Ezisurg Medical Co., Ltd. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2017
Date Received
September 26, 2017
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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