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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name clamp, circumcision
510(k) Number K131373
Device Name SHANGRING
Applicant
WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY
503 ROOM, 8 BUILDING, 600 LIU ZHOU ROAD
SHANGHAI,  CN 200233
Applicant Contact BO GONG
Correspondent
WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY
503 ROOM, 8 BUILDING, 600 LIU ZHOU ROAD
SHANGHAI,  CN 200233
Correspondent Contact BO GONG
Regulation Number884.4530
Classification Product Code
HFX  
Date Received05/13/2013
Decision Date 06/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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