The following data is part of a premarket notification filed by Remington Products Company, L.l.c. with the FDA for Remington Paraffin Spa, Models Hs-200. Pfs-600.
| Device ID | K013328 |
| 510k Number | K013328 |
| Device Name: | REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 |
| Classification | Bath, Paraffin |
| Applicant | REMINGTON PRODUCTS COMPANY, L.L.C. 1400 SIXTEENTH ST. N.W. SUITE 400 Washington, DC 20036 |
| Contact | Pamela J Furman |
| Correspondent | Pamela J Furman REMINGTON PRODUCTS COMPANY, L.L.C. 1400 SIXTEENTH ST. N.W. SUITE 400 Washington, DC 20036 |
| Product Code | IMC |
| CFR Regulation Number | 890.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-05 |
| Decision Date | 2001-12-03 |
| Summary: | summary |