The following data is part of a premarket notification filed by Jeneric Ind. with the FDA for Rx C & B 20.
Device ID | K840563 |
510k Number | K840563 |
Device Name: | RX C & B 20 |
Classification | Alloy, Other Noble Metal |
Applicant | JENERIC IND. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-08 |
Decision Date | 1984-05-01 |