K013328 is an FDA 510(k) clearance for the REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600. This device is classified as a Bath, Paraffin (Class II - Special Controls, product code IMC).
Submitted by Remington Products Company, LLC (Washington, US). The FDA issued a Cleared decision on December 3, 2001, 59 days after receiving the submission on October 5, 2001.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5110.
| 510(k) Number | K013328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2001 |
| Decision Date | December 03, 2001 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMC — Bath, Paraffin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5110 |