510(k) K093351
K093351 is an FDA 510(k) premarket notification submitted by Collamatrix, Inc. for the device "COLLAWOUND ART". The FDA issued a decision of Substantially Equivalent on Jun 16, 2010. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Collamatrix, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2010
- Date Received
- Oct 27, 2009
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)