510(k) K073034

AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) by Applied Medical Technology, Inc. — Product Code KNT

K073034 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)". The FDA issued a decision of Substantially Equivalent (kit) on March 14, 2008. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 14, 2008
Date Received
October 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type