The following data is part of a premarket notification filed by Remington Products Company, L.l.c. with the FDA for Remington Tanfastic Handheld Tanning Wand.
| Device ID | K895410 |
| 510k Number | K895410 |
| Device Name: | REMINGTON TANFASTIC HANDHELD TANNING WAND |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | REMINGTON PRODUCTS COMPANY, L.L.C. 60 MAIN ST. Bridgeport, CT 06604 |
| Contact | Kathleen Ivanko |
| Correspondent | Kathleen Ivanko REMINGTON PRODUCTS COMPANY, L.L.C. 60 MAIN ST. Bridgeport, CT 06604 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-11-27 |