The following data is part of a premarket notification filed by Light Sources, Inc. with the FDA for U.v. Sunlamp 95uf-11.
Device ID | K870167 |
510k Number | K870167 |
Device Name: | U.V. SUNLAMP 95UF-11 |
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 | 1987-01-14 |
Decision Date | 1987-02-09 |