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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 K013144
Device Name DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W
Applicant
C.R Bard, Inc.
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Applicant Contact MARION GORDON
Correspondent
C.R Bard, Inc.
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Correspondent Contact MARION GORDON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/20/2001
Decision Date 10/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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