510(k) K070269
K070269 is an FDA 510(k) premarket notification submitted by Collamatrix Co., Inc. for the device "MODIFICATION TO COLLAWOUND DRESSING". The FDA issued a decision of Substantially Equivalent on Mar 2, 2007. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Collamatrix Co., Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 2007
- Date Received
- Jan 29, 2007
- Clearance Type
- Special
- 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)