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FDA 510(k) Application Details - K071579
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K071579
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
N.M. BEALE CO. INC.
5 WHITCOMB AVENEUE
AYER, MA 01432 US
Other 510(k) Applications for this Company
Contact
PAMELA PAPINEAU
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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