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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 K893531
Device Name CUFF SPECULUM
Applicant
Mountain Medical Equipment, Inc.
10488 W. Centennial Rd.
Littleton,  CO  80127
Applicant Contact JAMES W MORGAN
Correspondent
Mountain Medical Equipment, Inc.
10488 W. Centennial Rd.
Littleton,  CO  80127
Correspondent Contact JAMES W MORGAN
Regulation Number876.5220
Classification Product Code
KPL  
Date Received05/08/1989
Decision Date 06/22/1989
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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