The following data is part of a premarket notification filed by Jk Holding Gmbh with the FDA for Ergoline Prestige 1600 Hybrid Performance.
| Device ID | K180555 |
| 510k Number | K180555 |
| Device Name: | Ergoline Prestige 1600 Hybrid Performance |
| 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 | 2018-03-01 |
| Decision Date | 2018-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EJKP100003549A0 | K180555 | 000 |