The following data is part of a premarket notification filed by Wolff System Technology Corp. with the FDA for Ultraviolet Sunlamps.
Device ID | K151841 |
510k Number | K151841 |
Device Name: | Ultraviolet Sunlamps |
Classification | Booth, Sun Tan |
Applicant | Wolff System Technology Corp. 980 Cobb Place Blvd N.W. Suite 200 Kennesaw, GA 30144 |
Contact | Michael Stepp |
Correspondent | Steven Schlitt Cosmedico Light, Inc. 233 Libbey Indistrial Pkwy Weymouth, MA 01860 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-06 |
Decision Date | 2015-10-05 |
Summary: | summary |