The following data is part of a premarket notification filed by Interlectric Corporation with the FDA for Suntanning Lamps.
Device ID | K152436 |
510k Number | K152436 |
Device Name: | Suntanning Lamps |
Classification | Booth, Sun Tan |
Applicant | Interlectric Corporation 1401 Lexington Ave. Warren, PA 16365 |
Contact | Ken C. Frazier |
Correspondent | Ken C. Frazier Interlectric Corporation 1401 Lexington Ave. Warren, PA 16365 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-27 |
Decision Date | 2015-12-07 |