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FDA 510(k) Application Details - K971137
Device Classification Name
Ligator, Esophageal
More FDA Info for this Device
510(K) Number
K971137
Device Name
Ligator, Esophageal
Applicant
C.R. BARD, INC.
129 CONCORD RD., BLDG. #3
BILLERICA, MA 01821 US
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Contact
BETH A ROCHETTE
Other 510(k) Applications for this Contact
Regulation Number
876.4400
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Classification Product Code
MND
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More FDA Info for this Product Code
Date Received
03/28/1997
Decision Date
10/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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