The following data is part of a premarket notification filed by Interlectric Corp. with the FDA for Suntanning Lamp.
Device ID | K864907 |
510k Number | K864907 |
Device Name: | SUNTANNING LAMP |
Classification | Light, Ultraviolet, Dermatological |
Applicant | INTERLECTRIC CORP. 1401 LEXINGTON AVE. Warren, PA 16365 |
Contact | David E Cochener |
Correspondent | David E Cochener INTERLECTRIC CORP. 1401 LEXINGTON AVE. Warren, PA 16365 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-15 |
Decision Date | 1987-01-05 |