510(k) K190528
K190528 is an FDA 510(k) premarket notification submitted by Kerecis Limited for the device "MariGen Wound Extra". The FDA issued a decision of Substantially Equivalent on July 10, 2019. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Kerecis Limited has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2019
- Date Received
- March 4, 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
- Regulation Number
- Review Panel
- SU
- Submission Type