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 |