The following data is part of a premarket notification filed by Feilo Sylvania Germany Gmbh with the FDA for Uv Lamps For Sunlamp Products.
Device ID | K180581 |
510k Number | K180581 |
Device Name: | UV Lamps For Sunlamp Products |
Classification | Booth, Sun Tan |
Applicant | Feilo Sylvania Germany GmbH Graf-Zepplin-Str.9 Erlangen, DE |
Contact | Achim Tonat |
Correspondent | Steve Mlcoch NATS Corp. PO Box 1257 30 Northport Rd. Sound Beach, NY 11789 |
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 | 2018-06-22 |
Summary: | summary |