The following data is part of a premarket notification filed by A & S Trading Co. with the FDA for Ultralite X-ray Film Illuminator.
Device ID | K922848 |
510k Number | K922848 |
Device Name: | ULTRALITE X-RAY FILM ILLUMINATOR |
Classification | Illuminator, Radiographic-film |
Applicant | A & S TRADING CO. 377 CAROWINDS BLVD. SUITE 203 Fort Mill, SC 29715 |
Contact | Robert Johnson |
Correspondent | Robert Johnson A & S TRADING CO. 377 CAROWINDS BLVD. SUITE 203 Fort Mill, SC 29715 |
Product Code | IXC |
CFR Regulation Number | 892.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-18 |
Decision Date | 1992-09-28 |