510(k) K232758
K232758 is an FDA 510(k) premarket notification submitted by Strukmyer Medical, LLC for the device "Comatryx OTC". The FDA issued a decision of Substantially Equivalent on December 1, 2023. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Strukmyer Medical, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2023
- Date Received
- September 8, 2023
- 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