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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 K971901
Device Name RADIUS LOW PROFILE GASTROSTOMY TUBE KIT
Applicant
RADIUS INTL., INC.
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Applicant Contact ED RANSOM
Correspondent
RADIUS INTL., INC.
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Correspondent Contact ED RANSOM
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/23/1997
Decision Date 01/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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