510(k) K113146
K113146 is an FDA 510(k) premarket notification submitted by Ross Healthcare, Inc. for the device "PCXX VARNISH". The FDA issued a decision of Substantially Equivalent on Jan 23, 2012. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 2012
- Date Received
- Oct 24, 2011
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type
- 510(k)