The following data is part of a premarket notification filed by Ross Healthcare Inc. with the FDA for Pcxx Varnish.
| Device ID | K113146 |
| 510k Number | K113146 |
| Device Name: | PCXX VARNISH |
| Classification | Varnish, Cavity |
| Applicant | ROSS HEALTHCARE INC. 1750 GRANT AVE Blaine, WA 98230 |
| Contact | Marc N Ross |
| Correspondent | Marc N Ross ROSS HEALTHCARE INC. 1750 GRANT AVE Blaine, WA 98230 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-10-24 |
| Decision Date | 2012-01-23 |
| Summary: | summary |