510(k) K863382
K863382 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "CANNON NASAL SPLINT". The FDA issued a decision of Substantially Equivalent on October 7, 1986. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 1986
- Date Received
- September 3, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Nasal
- Device Class
- Class I
- Regulation Number
- 874.5800
- Review Panel
- EN
- Submission Type