The following data is part of a premarket notification filed by Enamelite Llc with the FDA for Nova Ceramic Spray Glaze And Tru-paque, Opaque Porcelain.
| Device ID | K030859 |
| 510k Number | K030859 |
| Device Name: | NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN |
| Classification | Powder, Porcelain |
| Applicant | ENAMELITE LLC 1800 BUSINESS PARK DR. SUITE 406 Clarksville, TN 37040 |
| Contact | Phillip Pitts |
| Correspondent | Phillip Pitts ENAMELITE LLC 1800 BUSINESS PARK DR. SUITE 406 Clarksville, TN 37040 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-18 |
| Decision Date | 2003-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H668SPFGLZLG1 | K030859 | 000 |
| H66851001811 | K030859 | 000 |
| H66851001801 | K030859 | 000 |
| H66851001791 | K030859 | 000 |
| D754544002000 | K030859 | 000 |
| D745701124SHS00460 | K030859 | 000 |
| D745701124SHS00450 | K030859 | 000 |
| D745701124SHS00240 | K030859 | 000 |
| D745701124SHS00230 | K030859 | 000 |
| D745701124PUS00460 | K030859 | 000 |
| D745701124PUS00450 | K030859 | 000 |
| D745701124PUS00240 | K030859 | 000 |
| D745701124PUS00230 | K030859 | 000 |
| H66851001821 | K030859 | 000 |
| H66851001831 | K030859 | 000 |
| H668SPFGLZ1 | K030859 | 000 |
| H66851003161 | K030859 | 000 |
| H66851003151 | K030859 | 000 |
| H66851002141 | K030859 | 000 |
| H66851001971 | K030859 | 000 |
| H66851001961 | K030859 | 000 |
| H66851001911 | K030859 | 000 |
| H66851001881 | K030859 | 000 |
| H66851001871 | K030859 | 000 |
| H66851001861 | K030859 | 000 |
| H66851001851 | K030859 | 000 |
| H66851001841 | K030859 | 000 |
| D745701122OMB00570 | K030859 | 000 |