The following data is part of a premarket notification filed by Pascal Co., Inc. with the FDA for Fluorilaq.
| Device ID | K030488 |
| 510k Number | K030488 |
| Device Name: | FLUORILAQ |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-14 |
| Decision Date | 2003-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00310866001586 | K030488 | 000 |
| 00310866001579 | K030488 | 000 |
| 00310866001562 | K030488 | 000 |
| 00310866001104 | K030488 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLUORILAQ 76409910 not registered Dead/Abandoned |
Pascal Company, Inc. 2002-05-20 |