The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Molybdenum/rhodium Filters.
Device ID | K934686 |
510k Number | K934686 |
Device Name: | MOLYBDENUM/RHODIUM FILTERS |
Classification | Generator, High-voltage, X-ray, Diagnostic |
Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Contact | Oscar Khuyotysndky |
Correspondent | Oscar Khuyotysndky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
Product Code | IZO |
CFR Regulation Number | 892.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-29 |
Decision Date | 1994-05-26 |