The following data is part of a premarket notification filed by Remington Products Company, L.l.c. with the FDA for Remington Tanfastic Countertop Facial Tanner.
| Device ID | K895409 |
| 510k Number | K895409 |
| Device Name: | REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER |
| Classification | Booth, Sun Tan |
| 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 | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-10-20 |