510(k) K071557
K071557 is an FDA 510(k) premarket notification submitted by Collamatrix Co., Inc. for the device "COLLAWOUND HYDROGEL". The FDA issued a decision of Substantially Equivalent on Feb 8, 2008. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Collamatrix Co., Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 8, 2008
- Date Received
- Jun 7, 2007
- Clearance Type
- Traditional
- 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)