K895409 is an FDA 510(k) clearance for the REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER. This device is classified as a Booth, Sun Tan (Class II - Special Controls, product code LEJ).
Submitted by Remington Products Company, LLC (Bridgeport, US). The FDA issued a Cleared decision on October 20, 1989, 44 days after receiving the submission on September 6, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4635.
| 510(k) Number | K895409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1989 |
| Decision Date | October 20, 1989 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | LEJ — Booth, Sun Tan |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4635 |