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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K070451
Device Name ABLE CENTRAL VENOUS CATHETER
Applicant
Foshan Nanhai Bai HE Medical Technology Co., Ltd.
Suite 8d, #19 Lane 999,
Zhong Shan Nan Er Rd.
Shanghai,  CN 528200
Applicant Contact Diana Hong
Correspondent
Foshan Nanhai Bai HE Medical Technology Co., Ltd.
Suite 8d, #19 Lane 999,
Zhong Shan Nan Er Rd.
Shanghai,  CN 528200
Correspondent Contact Diana Hong
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/15/2007
Decision Date 07/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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