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FDA 510(k) Application Details - K041987
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K041987
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
07/23/2004
Decision Date
12/17/2004
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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