510(k) K100430
K100430 is an FDA 510(k) premarket notification submitted by Laboratoires Urgo for the device "URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER". The FDA issued a decision of Substantially Equivalent on Jun 11, 2010. 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
- Jun 11, 2010
- Date Received
- Feb 16, 2010
- Clearance Type
- Special
- 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)