510(k) K071056
K071056 is an FDA 510(k) premarket notification submitted by Novabay Pharmaceuticals for the device "NEUTROPHASE WOUND CLEANSER". The FDA issued a decision of Substantially Equivalent on September 28, 2007. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Novabay Pharmaceuticals has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2007
- Date Received
- April 16, 2007
- 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