The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Liebel-flarsheim Series 8000 Bucky,w/non Size Sens.
Device ID | K903160 |
510k Number | K903160 |
Device Name: | LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENS |
Classification | Table, Radiographic, Stationary Top |
Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Contact | Robert Walker |
Correspondent | Robert Walker CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Product Code | IXQ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-18 |
Decision Date | 1990-08-08 |