K895410 is an FDA 510(k) clearance for the REMINGTON TANFASTIC HANDHELD TANNING WAND. This device is classified as a Light, Ultraviolet, Dermatological (Class II - Special Controls, product code FTC).
Submitted by Remington Products Company, LLC (Bridgeport, US). The FDA issued a Cleared decision on November 27, 1989, 82 days after receiving the submission on September 6, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K895410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1989 |
| Decision Date | November 27, 1989 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FTC — Light, Ultraviolet, Dermatological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4630 |