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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K896896
Device Name KAWASUMI SMALL VEIN INFUSION SET
Applicant
Kawasumi Laboratories Co., Ltd.
15902 S. Western Ave.
# 200
Gardena,  CA  90247
Applicant Contact KENJIRO TANI
Correspondent
Kawasumi Laboratories Co., Ltd.
15902 S. Western Ave.
# 200
Gardena,  CA  90247
Correspondent Contact KENJIRO TANI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/08/1989
Decision Date 09/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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