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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barium Enema Kit
510(k) Number K864835
Device Name TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*
Applicant
Eisai U.S.A., Inc.
20908 Higgins Ct.
Torrance,  CA  90501
Applicant Contact MINORU ABE
Correspondent
Eisai U.S.A., Inc.
20908 Higgins Ct.
Torrance,  CA  90501
Correspondent Contact MINORU ABE
Regulation Number876.5210
Classification Product Code
FCD  
Date Received12/09/1986
Decision Date 02/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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