The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Ultrasun 4000 Ft & 15000-8 Suntanning Unit.
| Device ID | K860929 |
| 510k Number | K860929 |
| Device Name: | ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | William A Morton |
| Correspondent | William A Morton MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-11 |
| Decision Date | 1986-03-28 |