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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 K991375
Device Name BARD BALLOON INFLATION SYSTEM
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 Received04/21/1999
Decision Date 09/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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