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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonic Irrigation System
510(k) Number K881720
Device Name JIMMY JOHN III
Applicant
Colon Therapeutics
2729 Upton Dr.
Port Arthur,  TX  77642
Applicant Contact JIMMY GIROUARD
Correspondent
Colon Therapeutics
2729 Upton Dr.
Port Arthur,  TX  77642
Correspondent Contact JIMMY GIROUARD
Regulation Number876.5220
Classification Product Code
KPL  
Date Received04/21/1988
Decision Date 07/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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