The following data is part of a premarket notification filed by Pascal Co., Inc. with the FDA for Fluorilaq Sodium Fluoride Cavity Varnish.
| Device ID | K090597 |
| 510k Number | K090597 |
| Device Name: | FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH |
| Classification | Varnish, Cavity |
| Applicant | PASCAL CO., INC. 2929 N.E. NORTHUP WAY Bellevue, WA 98004 |
| Contact | Vincent M Tentarelli |
| Correspondent | Vincent M Tentarelli PASCAL CO., INC. 2929 N.E. NORTHUP WAY Bellevue, WA 98004 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-03-05 |
| Decision Date | 2009-03-16 |
| Summary: | summary |