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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 K100163
Device Name NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
Applicant
Vygon Corp.
103a Park Rd.
Montgomeryville,  PA  18936
Applicant Contact CINDY VARUGHESE
Correspondent
Vygon Corp.
103a Park Rd.
Montgomeryville,  PA  18936
Correspondent Contact CINDY VARUGHESE
Regulation Number876.5980
Classification Product Code
FPD  
Date Received01/20/2010
Decision Date 10/13/2011
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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