510(k) K052696
K052696 is an FDA 510(k) premarket notification submitted by Covalon Technologies, Ltd. for the device "COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING". The FDA issued a decision of Substantially Equivalent on February 3, 2006. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Covalon Technologies, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2006
- Date Received
- September 28, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type