The following data is part of a premarket notification filed by Jk-holding Gmbh with the FDA for Sunrise 6200, Sunrise 7200.
Device ID | K173565 |
510k Number | K173565 |
Device Name: | Sunrise 6200, Sunrise 7200 |
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 | 2017-11-17 |
Decision Date | 2018-02-14 |
Summary: | summary |