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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 K910492
Device Name BARD REPLACEMENT GASTROSTOMY TUBE
Applicant
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Applicant Contact JOHN HOFFER
Correspondent
C.R. Bard, Inc.
111 Spring St.
Murray Hill,  NJ  07974
Correspondent Contact JOHN HOFFER
Regulation Number876.5980
Classification Product Code
KGC  
Date Received02/05/1991
Decision Date 07/24/1991
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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