510(k) K202623
K202623 is an FDA 510(k) premarket notification submitted by Medtronic Xomed for the device "Novapak Nasal Sinus Packing and Stent". The FDA issued a decision of Substantially Equivalent on Dec 8, 2020. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Medtronic Xomed has 46 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 8, 2020
- Date Received
- Sep 10, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Intranasal Septal
- Device Class
- Class I
- Regulation Number
- 874.4780
- Review Panel
- EN
- Submission Type
- 510(k) Exempt