510(k) K110804
K110804 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT G-J TUBE". The FDA issued a decision of Substantially Equivalent (kit) on October 19, 2011. 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
- October 19, 2011
- Date Received
- March 22, 2011
- 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