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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 K946249
Device Name BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES
Applicant
C.R. BARD, INC.
200 AMES POND DR.
TEWKSBURY,  MA  01876
Applicant Contact JOHN A DELUCIA
Correspondent
C.R. BARD, INC.
200 AMES POND DR.
TEWKSBURY,  MA  01876
Correspondent Contact JOHN A DELUCIA
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/23/1994
Decision Date 12/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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