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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 K103470
Device Name PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP
Applicant
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
Rm. 1606 Bldg. 1 Jianxiang Yu
# 209 Bei Si Huan
Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
Rm. 1606 Bldg. 1 Jianxiang Yu
# 209 Bei Si Huan
Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received11/26/2010
Decision Date 01/11/2011
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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