The following data is part of a premarket notification filed by Scandinavian Formulas, Inc. with the FDA for Slivasure.
| Device ID | K051409 |
| 510k Number | K051409 |
| Device Name: | SLIVASURE |
| Classification | Stains, Chemical Solution |
| Applicant | SCANDINAVIAN FORMULAS, INC. 140 EAST CHURCH ST. Sellersville, PA 18960 |
| Contact | Catherine P Peklak |
| Correspondent | Catherine P Peklak SCANDINAVIAN FORMULAS, INC. 140 EAST CHURCH ST. Sellersville, PA 18960 |
| Product Code | LED |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2005-08-08 |