FDA 510(k) Application Details - K071579

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K071579
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant N.M. BEALE CO. INC.
5 WHITCOMB AVENEUE
AYER, MA 01432 US
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Contact PAMELA PAPINEAU
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 06/08/2007
Decision Date 11/20/2007
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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