FDA 510(k) Application Details - K013144

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K013144
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant C.R. BARD, INC.
129 CONCORD RD., BLDG. #3
BILLERICA, MA 01821 US
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Contact MARION GORDON
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 09/20/2001
Decision Date 10/19/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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