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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 K024007
Device Name SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J
Applicant
Sunder Biomedical Tech. Co., Ltd.
10f-1, 1-67, Wu-Chuan Rd.
Taichung City,  TW 403
Applicant Contact TONY HUNG
Correspondent
Sunder Biomedical Tech. Co., Ltd.
10f-1, 1-67, Wu-Chuan Rd.
Taichung City,  TW 403
Correspondent Contact TONY HUNG
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/04/2002
Decision Date 07/14/2003
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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