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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention, Barium Enema With Bag
510(k) Number K905026
Device Name DUAL FLEX NON-LATEX
Applicant
Mmi, Inc.
19500 W. Eight Mile Rd.
P.O. Box 305
Southfield,  MI  48037
Applicant Contact MATTLER
Correspondent
Mmi, Inc.
19500 W. Eight Mile Rd.
P.O. Box 305
Southfield,  MI  48037
Correspondent Contact MATTLER
Regulation Number876.5980
Classification Product Code
FGD  
Date Received11/07/1990
Decision Date 12/18/1991
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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