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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 K072756
Device Name NON-IV ADAPTER FOR INFANT NG TUBE
Applicant
PROMEDIC, INC.
3460 POINTE CREEK CT., #102
BONITA SPRINGS,  FL  34134 -2015
Applicant Contact PAUL DRYDEN
Correspondent
PROMEDIC, INC.
3460 POINTE CREEK CT., #102
BONITA SPRINGS,  FL  34134 -2015
Correspondent Contact PAUL DRYDEN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/27/2007
Decision Date 12/19/2007
Decision Substantially Equivalent - Kit (SESK)
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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