510(k) K081009
K081009 is an FDA 510(k) premarket notification submitted by Novabay Pharmaceuticals for the device "NEUTROPHASE". The FDA issued a decision of Substantially Equivalent on May 20, 2008. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Novabay Pharmaceuticals has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2008
- Date Received
- April 8, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Liquid
- Device Class
- Class I
- Regulation Number
- 880.5090
- Review Panel
- SU
- Submission Type