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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 K863539
Device Name HYDRO-CLENZ UNIT
Applicant
Atlantic Health Group
6400 Atlantic Blvd., Suite
175
Norcross,  GA  30071
Applicant Contact ROY ABELL
Correspondent
Atlantic Health Group
6400 Atlantic Blvd., Suite
175
Norcross,  GA  30071
Correspondent Contact ROY ABELL
Regulation Number876.5220
Classification Product Code
KPL  
Date Received09/11/1986
Decision Date 10/16/1986
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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