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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 K100723
Device Name DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5
Applicant
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.
77325 JOYCE WAY
ECHO,  OR  97826
Applicant Contact CHARLIE MACK
Correspondent
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.
77325 JOYCE WAY
ECHO,  OR  97826
Correspondent Contact CHARLIE MACK
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/15/2010
Decision Date 04/30/2010
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
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