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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, gastro-enterostomy
510(k) Number K901795
Device Name GASTROSTOMY FEEDING CATHETER
Applicant
SOUTHSIDE BIOTECHNOLOGY
37220 BEECH HILLS DR.
WILLOUGHBY HILLS,  OH  44094
Applicant Contact DENNIS J SIEDLAK
Correspondent
SOUTHSIDE BIOTECHNOLOGY
37220 BEECH HILLS DR.
WILLOUGHBY HILLS,  OH  44094
Correspondent Contact DENNIS J SIEDLAK
Regulation Number876.5980
Classification Product Code
KGC  
Date Received04/19/1990
Decision Date 08/08/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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