510(k) K073034
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