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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 K843792
Device Name VAN JON SUPER CLYSTER(KIT, ENEMA
Applicant
Van Jon Co.
15025 Saticox St. #7
Van Nuys,  CA  91405
Applicant Contact LLOYD V IVES
Correspondent
Van Jon Co.
15025 Saticox St. #7
Van Nuys,  CA  91405
Correspondent Contact LLOYD V IVES
Regulation Number876.5210
Classification Product Code
FCE  
Date Received09/27/1984
Decision Date 04/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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