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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K855121
Device Name COLOSHIELD KIT
Applicant
DEKNATEL, INC.
2300 MARCUS AVE.
LAKE SUCCESS,  NY  11042
Applicant Contact OROFINO
Correspondent
DEKNATEL, INC.
2300 MARCUS AVE.
LAKE SUCCESS,  NY  11042
Correspondent Contact OROFINO
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/23/1985
Decision Date 01/08/1986
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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