The following data is part of a premarket notification filed by Radkor, Inc. with the FDA for Radkor, Rf-159.
Device ID | K883885 |
510k Number | K883885 |
Device Name: | RADKOR, RF-159 |
Classification | Table, Radiologic |
Applicant | RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
Contact | Jack E Briggs |
Correspondent | Jack E Briggs RADKOR, INC. 16610 ASTON ST. Irvine, CA 92714 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-13 |
Decision Date | 1988-10-19 |