510(k) DEN040004
DEN040004 is an FDA 510(k) premarket notification submitted by Celleration for the device "CELLERATION MIST THERAPY SYSTEM". The FDA issued a decision of De Novo Granted on June 25, 2004. The device falls under product code NRB (Wound Cleaner, Ultrasound), a Class II device regulated under 21 CFR 878.4410. Celleration has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 25, 2004
- Date Received
- April 29, 2004
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Cleaner, Ultrasound
- Device Class
- Class II
- Regulation Number
- 878.4410
- Review Panel
- SU
- Submission Type
The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound