The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Liebel-flarsheim Afc 1000 X-ray Film.
Device ID | K841732 |
510k Number | K841732 |
Device Name: | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM |
Classification | Programmer, Changer, Film/cassette, Radiographic |
Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IZP |
CFR Regulation Number | 892.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-26 |
Decision Date | 1984-06-05 |