510(k) K230444
K230444 is an FDA 510(k) premarket notification submitted by Invent Medical USA, LLC for the device "Talee, Talee PostOp". The FDA issued a decision of Substantially Equivalent on June 22, 2023. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970. Invent Medical USA, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2023
- Date Received
- February 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cranial
- Device Class
- Class II
- Regulation Number
- 882.5970
- Review Panel
- NE
- Submission Type