The following data is part of a premarket notification filed by Blv Licht-und Vakuumtechnik Gmbh with the FDA for High Pressure Tanning Lamps.
Device ID | K152141 |
510k Number | K152141 |
Device Name: | High Pressure Tanning Lamps |
Classification | Booth, Sun Tan |
Applicant | BLV Licht-und Vakuumtechnik GmbH Munchener Strasse 10 Steinhoring, DE 85643 |
Contact | Heinz-jurgen Wesseling |
Correspondent | Heinz-jurgen Wesseling BLV Licht-und Vakuumtechnik GmbH Munchener Strasse 10 Steinhoring, DE 85643 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-03 |
Decision Date | 2016-02-25 |