The following data is part of a premarket notification filed by Pc Marketing, Inc. with the FDA for Uwe Sun Tanning Beds/booths P90, Ibed Evg, Isun Hp, Silverbullet Se, Lotus.
| Device ID | K152364 |
| 510k Number | K152364 |
| Device Name: | Uwe Sun Tanning Beds/booths P90, IBED EVG, ISUN HP, SILVERBULLET SE, LOTUS |
| Classification | Booth, Sun Tan |
| Applicant | PC Marketing, Inc. 1040 Wilt Avenue Ridgefield, NJ 07657 |
| Contact | Michael Rolls |
| Correspondent | Shepard G. Bentley BENTLEY BIOMEDICAL CONSULTING, LLC. 28241 CROWN VALLEY PARKWAY Laguna Niguel, CA 92677 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-21 |
| Decision Date | 2016-04-14 |