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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K935506
Device Name MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION
Applicant
Kawasumi Laboratories Co., Ltd.
3-28-15 Minami Ohi, Shinagawa-
Ku
Tokyo,  JP 140
Applicant Contact SHOZO MORIYAMA
Correspondent
Kawasumi Laboratories Co., Ltd.
3-28-15 Minami Ohi, Shinagawa-
Ku
Tokyo,  JP 140
Correspondent Contact SHOZO MORIYAMA
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/16/1993
Decision Date 02/03/1994
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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