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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K172538
Device Name Disposable Linear Stapler, Disposable Linear Cutter
Applicant
Changzhou Kangdi Medical Stapler Co., Ltd.
# 16 Kunlun Rd., Xinbei Zone
Changzhou City,  CN 213022
Applicant Contact Eve Zhou
Correspondent
Irc
2091 Oak Dr.
Lake Havasu City,  AZ  86406
Correspondent Contact Charlie Mack
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/22/2017
Decision Date 11/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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