The following data is part of a premarket notification filed by Infab Corp. with the FDA for Radiographic Grid.
Device ID | K901012 |
510k Number | K901012 |
Device Name: | RADIOGRAPHIC GRID |
Classification | Grid, Radiographic |
Applicant | INFAB CORP. 3651 VIA PESCADOR Camarillo, CA 93012 |
Contact | Don Cusick |
Correspondent | Don Cusick INFAB CORP. 3651 VIA PESCADOR Camarillo, CA 93012 |
Product Code | IXJ |
CFR Regulation Number | 892.1910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-05 |
Decision Date | 1990-03-28 |