510(k) K123756
K123756 is an FDA 510(k) premarket notification submitted by Covalon Technologies, Ltd. for the device "COVAGEN". The FDA issued a decision of Substantially Equivalent on August 16, 2013. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Covalon Technologies, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2013
- Date Received
- December 7, 2012
- 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