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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 K152618
Device Name PANTHER Cutter Stapler
Applicant
B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD
ROOM 3305A, FLOOR 3, BLDG 3, NO.208 BLOCK 2 LIZA PARK,
WANGJING INDUSTRIAL DIST.
BEIJING,  CN 100102
Applicant Contact LINA YUN
Correspondent
MID-LINK CONSULTING CO.,LTD
P.O. BOX 120-119
SHANGHAI,  CN 200120
Correspondent Contact DIANA HONG
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received09/14/2015
Decision Date 11/12/2015
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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