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FDA 510(k) Application Details - K063061
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K063061
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
VIASYS MEDSYSTEMS
100 CHADDICK DR.
WHEELING, IL 60090 US
Other 510(k) Applications for this Company
Contact
STEPHANIE WASIELEWSKI
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
10/05/2006
Decision Date
04/02/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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