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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enema kit
510(k) Number K881218
Device Name GENT-L-KARE CLEANSING ENEMA SET
Applicant
GENEVA LABORATORIES, INC.
P.O. BOX 444
ELKHORN,  WI  53121
Applicant Contact GARY L SWANSON
Correspondent
GENEVA LABORATORIES, INC.
P.O. BOX 444
ELKHORN,  WI  53121
Correspondent Contact GARY L SWANSON
Regulation Number876.5210
Classification Product Code
FCE  
Date Received03/22/1988
Decision Date 07/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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