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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 K885092
Device Name BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002
Applicant
Medical Imaging Systems, Inc.
2605 Cabover Dr., Suite #11
Hanover,  MD  21076
Applicant Contact JERRY J DITZEL
Correspondent
Medical Imaging Systems, Inc.
2605 Cabover Dr., Suite #11
Hanover,  MD  21076
Correspondent Contact JERRY J DITZEL
Regulation Number876.5220
Classification Product Code
KPL  
Date Received12/12/1988
Decision Date 03/10/1989
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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