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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 K003311
Device Name NUTRISAFE PUR ENTERAL FEEDING TUBE
Applicant
VYGON CORP.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
VYGON CORP.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number876.5980
Classification Product Code
FPD  
Date Received10/23/2000
Decision Date 01/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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