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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 K870796
Device Name MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY
Applicant
Plasco, Inc.
3849 Swanson St.
Gurnee,  IL  60031 -1225
Applicant Contact MICHAEL S FALES
Correspondent
Plasco, Inc.
3849 Swanson St.
Gurnee,  IL  60031 -1225
Correspondent Contact MICHAEL S FALES
Regulation Number876.5210
Classification Product Code
FCE  
Date Received02/27/1987
Decision Date 04/01/1987
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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