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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 K121474
Device Name DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
Applicant
Changzhou Kangdi Medical Stapler Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Applicant Contact CHARLES MACK
Correspondent
Changzhou Kangdi Medical Stapler Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Correspondent Contact CHARLES MACK
Regulation Number878.4750
Classification Product Code
GDW  
Date Received05/18/2012
Decision Date 07/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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