510(k) K220498
K220498 is an FDA 510(k) premarket notification submitted by Novabone Products, LLC for the device "NovoGen Wound Matrix". The FDA issued a decision of Substantially Equivalent on Jun 9, 2023. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Novabone Products, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 9, 2023
- Date Received
- Feb 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type