The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Durafinish All-cure, Model S296.
| Device ID | K080549 |
| 510k Number | K080549 |
| Device Name: | DURAFINISH ALL-CURE, MODEL S296 |
| Classification | Coating, Filling Material, Resin |
| Applicant | PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
| Contact | Daniel R Schechter, Esq |
| Correspondent | Daniel R Schechter, Esq PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-27 |
| Decision Date | 2008-05-13 |
| Summary: | summary |