The following data is part of a premarket notification filed by Apollo's Suntanning Supplies with the FDA for Phase V-model 1500 Ruva.
Device ID | K854131 |
510k Number | K854131 |
Device Name: | PHASE V-MODEL 1500 RUVA |
Classification | Light, Ultraviolet, Dermatological |
Applicant | APOLLO'S SUNTANNING SUPPLIES 626 NORTH & SOUTH RD. University City, MO 63130 |
Contact | Gretchen M Engel |
Correspondent | Gretchen M Engel APOLLO'S SUNTANNING SUPPLIES 626 NORTH & SOUTH RD. University City, MO 63130 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-10 |
Decision Date | 1985-11-08 |