The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Ba-93.
Device ID | K811407 |
510k Number | K811407 |
Device Name: | BA-93 |
Classification | Alloy, Metal, Base |
Applicant | DERINGER-NEY INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-19 |
Decision Date | 1981-06-16 |