The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Modif Top Drive Board Cxt-90 90/90 Diag Tilt Table.
Device ID | K912996 |
510k Number | K912996 |
Device Name: | MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE |
Classification | Table, Radiographic, Tilting |
Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Contact | Ocsar Khutoryansky |
Correspondent | Ocsar Khutoryansky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-08 |
Decision Date | 1992-02-03 |