510(k) K120272
K120272 is an FDA 510(k) premarket notification submitted by Kentec Medical, Inc. for the device "AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET". The FDA issued a decision of Substantially Equivalent on February 17, 2012. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Kentec Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2012
- Date Received
- January 30, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type