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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 K872006
Device Name DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF
Applicant
Mac Lee Medical Products
2900 SW Atwood
Topeka,  KS  66614
Applicant Contact GEORGE E LIESMANN
Correspondent
Mac Lee Medical Products
2900 SW Atwood
Topeka,  KS  66614
Correspondent Contact GEORGE E LIESMANN
Regulation Number876.5980
Classification Product Code
FGD  
Date Received05/26/1987
Decision Date 11/17/1987
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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