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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 K904779
Device Name BUTTON REPLACEMENT GASTROSTOMY DEVICE
Applicant
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Applicant Contact ERNEST MANFREDO
Correspondent
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Correspondent Contact ERNEST MANFREDO
Regulation Number876.5980
Classification Product Code
KGC  
Date Received10/22/1990
Decision Date 01/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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