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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infusor, Pressure, For I.V. Bags
510(k) Number K930012
Device Name KAWASUMI LABORATORIES K-CUFF
Applicant
Kawasumi Laboratories Co., Ltd.
Kawasumi Bldg. 3-28-15
Minami-Ohi, Shinagawa-Ku
Tokyo,  JP 140
Applicant Contact SHOZO MORIYAMA
Correspondent
Kawasumi Laboratories Co., Ltd.
Kawasumi Bldg. 3-28-15
Minami-Ohi, Shinagawa-Ku
Tokyo,  JP 140
Correspondent Contact SHOZO MORIYAMA
Regulation Number880.5420
Classification Product Code
KZD  
Date Received01/04/1993
Decision Date 12/14/1993
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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