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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, nasogastric
510(k) Number K930510
Device Name RADIUS ENTERAL FEEDING TUBE
Applicant
RADIUS INTL., INC.
21860 WEST WASHINGTON ST.
GRAYSLAKE,  IL  60030
Applicant Contact DAVID G QUINN
Correspondent
RADIUS INTL., INC.
21860 WEST WASHINGTON ST.
GRAYSLAKE,  IL  60030
Correspondent Contact DAVID G QUINN
Regulation Number876.5980
Classification Product Code
BSS  
Date Received02/01/1993
Decision Date 02/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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