The following data is part of a premarket notification filed by Excel Medical Products, Inc. with the FDA for Excelview Illuminator.
Device ID | K883702 |
510k Number | K883702 |
Device Name: | EXCELVIEW ILLUMINATOR |
Classification | Illuminator, Radiographic-film |
Applicant | EXCEL MEDICAL PRODUCTS, INC. 2610-4 WEST MARSHALL DR. Grand Prairie, TX 75051 |
Contact | Scott T Jones |
Correspondent | Scott T Jones EXCEL MEDICAL PRODUCTS, INC. 2610-4 WEST MARSHALL DR. Grand Prairie, TX 75051 |
Product Code | IXC |
CFR Regulation Number | 892.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-30 |
Decision Date | 1988-09-19 |