510(k) K162046
K162046 is an FDA 510(k) premarket notification submitted by Summit Medical, Inc. for the device "MINNE TIES MMF Suture System". The FDA issued a decision of Substantially Equivalent on April 11, 2017. The device falls under product code DYX (Lock, Wire, And Ligature, Intraoral), a Class II device regulated under 21 CFR 872.4600. Summit Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2017
- Date Received
- July 25, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lock, Wire, And Ligature, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.4600
- Review Panel
- DE
- Submission Type