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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 K953375
Device Name NG SECURE
Applicant
M.C. JOHNSON CO., INC.
4292 CORPORATE SQUARE
SUITE C
NAPLES,  FL  33942 -4753
Applicant Contact PHILIP BAKER
Correspondent
M.C. JOHNSON CO., INC.
4292 CORPORATE SQUARE
SUITE C
NAPLES,  FL  33942 -4753
Correspondent Contact PHILIP BAKER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/18/1995
Decision Date 09/08/1995
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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