The following data is part of a premarket notification filed by Unidex Group, Inc. with the FDA for Radiographic Grid.
Device ID | K962338 |
510k Number | K962338 |
Device Name: | RADIOGRAPHIC GRID |
Classification | Grid, Radiographic |
Applicant | UNIDEX GROUP, INC. 2400 EAST DEVON AVE. Des Plaines, IL 60018 |
Contact | Henry Lee |
Correspondent | Henry Lee UNIDEX GROUP, INC. 2400 EAST DEVON AVE. Des Plaines, IL 60018 |
Product Code | IXJ |
CFR Regulation Number | 892.1910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-17 |
Decision Date | 1996-07-03 |