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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 K913603
Device Name FIBRETWINS
Applicant
ORAL-B LABORATORIES
ONE LAGOON DR.
REDWOOD CITY,  CA  94065
Applicant Contact SHARON SNYDER
Correspondent
ORAL-B LABORATORIES
ONE LAGOON DR.
REDWOOD CITY,  CA  94065
Correspondent Contact SHARON SNYDER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/14/1991
Decision Date 09/30/1991
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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