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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 K884439
Device Name GASTROSTOMY FEEDING DEVICE
Applicant
SOUTHSIDE BIOTECHNOLOGY
3249 JUPITER DR.
NORTH ROYALTON,  OH  44133
Applicant Contact JEFFREY A GIRIMONT
Correspondent
SOUTHSIDE BIOTECHNOLOGY
3249 JUPITER DR.
NORTH ROYALTON,  OH  44133
Correspondent Contact JEFFREY A GIRIMONT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/21/1988
Decision Date 12/05/1988
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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