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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 K142577
Device Name PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
Applicant
B.J.Z.H.F. Panther Medical Equipment Co. Ltd.
ROM 805, Ruichuang Mansion, NO. 9 Wangjing East
Beijing,  CN
Applicant Contact Liu Yu
Correspondent
CHU XIAOAN
Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan ZhongRd
Beijing,  CN
Correspondent Contact Chu Xiaoan
Regulation Number878.4750
Classification Product Code
GDW  
Date Received09/12/2014
Decision Date 06/11/2015
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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