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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 K083429
Device Name I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT
Applicant
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD.
STE 8D, NO.19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI,  CN 200030
Applicant Contact Diana Hong
Correspondent
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD.
STE 8D, NO.19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI,  CN 200030
Correspondent Contact Diana Hong
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/19/2008
Decision Date 08/07/2009
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
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