510(k) K142989
K142989 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "Mini ONE Enteral Extension Set". The FDA issued a decision of Substantially Equivalent on January 29, 2015. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), 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
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2015
- Date Received
- October 16, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Tubes With Enteral Specific Connectors
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
To facilitate enteral specific connections.