The following data is part of a premarket notification filed by Fancy Tan, Inc. with the FDA for Fancy Tan Sunbed.
Device ID | K810366 |
510k Number | K810366 |
Device Name: | FANCY TAN SUNBED |
Classification | Booth, Sun Tan |
Applicant | FANCY TAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-12 |
Decision Date | 1981-03-05 |