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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 K884275
Device Name FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
Applicant
ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215
Applicant Contact MICHAEL H HANEY
Correspondent
ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215
Correspondent Contact MICHAEL H HANEY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/12/1988
Decision Date 12/22/1988
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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