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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 K901791
Device Name PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH.
Applicant
Southside Biotechnology
37220 Beech Hills Dr.
Willoughby Hills,  OH  44094
Applicant Contact J SIEDLAK
Correspondent
Southside Biotechnology
37220 Beech Hills Dr.
Willoughby Hills,  OH  44094
Correspondent Contact 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
Predetermined Change
Control Plan Authorized		 No
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