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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 K842130
Device Name G.I. CLEANSING KIT
Applicant
Mmi, Inc.
19500 W. Eight Mile Rd.
P.O. Box 305
Southfield,  MI  48037
Applicant Contact MARTIN MATTLER
Correspondent
Mmi, Inc.
19500 W. Eight Mile Rd.
P.O. Box 305
Southfield,  MI  48037
Correspondent Contact MARTIN MATTLER
Regulation Number876.5210
Classification Product Code
FCE  
Date Received05/30/1984
Decision Date 08/08/1984
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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