The following data is part of a premarket notification filed by David Connell with the FDA for Suntainning Booth.
Device ID | K854707 |
510k Number | K854707 |
Device Name: | SUNTAINNING BOOTH |
Classification | Light, Ultraviolet, Dermatological |
Applicant | DAVID CONNELL 69 HOMEFIELD AVE. Providence, RI 02908 |
Contact | David Connell |
Correspondent | David Connell DAVID CONNELL 69 HOMEFIELD AVE. Providence, RI 02908 |
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 | 1985-11-20 |
Decision Date | 1986-01-30 |