510(k) K192346
K192346 is an FDA 510(k) premarket notification submitted by Freudenberg Technology Innovation SE & Co. KG for the device "scaffolene CL100 Bioresorbable Collagen Matrix". The FDA issued a decision of Substantially Equivalent on Feb 28, 2020. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 2020
- Date Received
- Aug 29, 2019
- 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
- Review Panel
- SU
- Submission Type
- 510(k)