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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K974806
Device Name VYGON NEO-SUMP
Applicant
VYGON CORP.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Applicant Contact ANNE MARIE CESARIO
Correspondent
VYGON CORP.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Correspondent Contact ANNE MARIE CESARIO
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/23/1997
Decision Date 03/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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