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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 K022558
Device Name NGT
Applicant
MEDICAL INNOVATIVE PRODUCTS
7 TIFFANY TRAIL
HOPKINTON,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
MEDICAL INNOVATIVE PRODUCTS
7 TIFFANY TRAIL
HOPKINTON,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/02/2002
Decision Date 07/08/2003
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
Predetermined Change
Control Plan Authorized		 No
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