510(k) K181838
K181838 is an FDA 510(k) premarket notification submitted by 3nt Medical , Ltd. for the device "Sinusway Dilation System". The FDA issued a decision of Substantially Equivalent on December 20, 2018. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. 3nt Medical , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2018
- Date Received
- July 10, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ent Manual Surgical
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type