The following data is part of a premarket notification filed by Light Sources, Inc. with the FDA for Fluorescent T12 Uva Lamp.
Device ID | K900649 |
510k Number | K900649 |
Device Name: | FLUORESCENT T12 UVA LAMP |
Classification | Light, Ultraviolet, Dermatological |
Applicant | LIGHT SOURCES, INC. P.O. BOX 569 410 MAIN ST. Ansonia, CT 06401 |
Contact | Gene Czako |
Correspondent | Gene Czako LIGHT SOURCES, INC. P.O. BOX 569 410 MAIN ST. Ansonia, CT 06401 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-09 |
Decision Date | 1990-03-28 |