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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 K060944
Device Name NUTRISAFE 2
Applicant
Vygon Corp.
2495 General Armistead Ave.
Norristown,  PA  19403
Applicant Contact COURTNEY SMITH
Correspondent
Vygon Corp.
2495 General Armistead Ave.
Norristown,  PA  19403
Correspondent Contact COURTNEY SMITH
Regulation Number876.5980
Classification Product Code
FPD  
Subsequent Product Code
KNT  
Date Received04/06/2006
Decision Date 09/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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