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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 Rd.
Montgomeryville,  PA  18936
Applicant Contact JILLIAN MIKOVICH
Correspondent
Vygon Corp.
103a Park Rd.
Montgomeryville,  PA  18936
Correspondent Contact JILLIAN MIKOVICH
Regulation Number876.5980
Classification Product Code
FPD  
Date Received04/12/2012
Decision Date 12/18/2012
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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