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FDA 510(k) Application Details - K183508
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K183508
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
Applied Medical Technology, Inc.
8006 Katherine Boulevard
Brecksville, OH 44141 US
Other 510(k) Applications for this Company
Contact
Joy Tubero
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2018
Decision Date
03/29/2019
Decision
SESK - SUBST EQUIV - KIT
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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