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FDA 510(k) Application Details - K950017
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K950017
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
ROSS PRODUCTS
625 CLEVELAND AVE.
COLUMBUS, OH 43215-1724 US
Other 510(k) Applications for this Company
Contact
MICHAEWL H HANEY
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
01/03/1995
Decision Date
03/14/1997
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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