510(k) K123219
K123219 is an FDA 510(k) premarket notification submitted by Laboratoires Urgo for the device "URGOCLEAN ABSORBENT WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on Mar 18, 2013. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Laboratoires Urgo has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 18, 2013
- Date Received
- Oct 15, 2012
- 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)