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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K973500
FOIA Releasable 510(k) K973500
Device Name BARD ENDOSCOPIC OVERTUBE (#000307)
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 Number876.1500
Classification Product Code
FED  
Date Received09/16/1997
Decision Date 10/16/1997
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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