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510(k) K182217

Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use by Ezisurg (Suzhou) Medical Co., Ltd. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2019
Date Received
August 15, 2018
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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