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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, feeding
510(k) Number K072831
Device Name FROG
Applicant
NEWBY-COOMBS, LLC
21 UNION TURNPIKE
BRANCHVILLE,  NJ  07826
Applicant Contact KARLA COOMBS
Correspondent
NEWBY-COOMBS, LLC
21 UNION TURNPIKE
BRANCHVILLE,  NJ  07826
Correspondent Contact KARLA COOMBS
Regulation Number876.5980
Classification Product Code
FPD  
Date Received10/03/2007
Decision Date 12/12/2008
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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