The following data is part of a premarket notification filed by North American Philips Corp. with the FDA for Uva Fluorescent Tanning Lamps.
Device ID | K813451 |
510k Number | K813451 |
Device Name: | UVA FLUORESCENT TANNING LAMPS |
Classification | Lamp, Infrared, Non Heating |
Applicant | NORTH AMERICAN PHILIPS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IOB |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-12-10 |
Decision Date | 1982-01-28 |