The following data is part of a premarket notification filed by Phoenix U.v.a. Ltd. with the FDA for Phoenix U.v.a. Suntan Beds.
Device ID | K854594 |
510k Number | K854594 |
Device Name: | PHOENIX U.V.A. SUNTAN BEDS |
Classification | Light, Ultraviolet, Dermatological |
Applicant | PHOENIX U.V.A. LTD. 413 FIRST ST. Meservey, IA 50457 |
Contact | Mark Gard |
Correspondent | Mark Gard PHOENIX U.V.A. LTD. 413 FIRST ST. Meservey, IA 50457 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-18 |
Decision Date | 1986-01-30 |