510(k) K060804
K060804 is an FDA 510(k) premarket notification submitted by Covalon Technologies, Ltd. for the device "COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on April 18, 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
- April 18, 2006
- Date Received
- March 24, 2006
- Clearance Type
- Special
- 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