The following data is part of a premarket notification filed by Jk Holding Gmbh with the FDA for Ergoline, Sun Angel, Soltron, Sundash And Palm Beach Tan Sunlamp Products.
| Device ID | K151400 |
| 510k Number | K151400 |
| Device Name: | Ergoline, Sun Angel, Soltron, Sundash And Palm Beach Tan Sunlamp Products |
| Classification | Booth, Sun Tan |
| Applicant | JK HOLDING GmbH KOEHLERSHOHNER STRASSE 60 Windhagen, DE 53578 |
| Contact | Juergen Gerstenmeier |
| Correspondent | Juergen Gerstenmeier JK HOLDING GmbH KOEHLERSHOHNER STRASSE 60 Windhagen, DE 53578 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2015-09-16 |
| Summary: | summary |