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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 K121105
Device Name NUTRISAFE 2 FEEDING TUBE
Applicant
VYGON CORP.
103a park road
montgomeryville,  PA  18936
Contact jillian mikovich
Regulation Number876.5980
Classification Product Code
FPD  
Date Received04/12/2012
Decision Date 12/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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