The following data is part of a premarket notification filed by Bauer, Cheng & Associates, Inc. with the FDA for Rx 91.
| Device ID | K823100 |
| 510k Number | K823100 |
| Device Name: | RX 91 |
| Classification | Alloy, Other Noble Metal |
| Applicant | BAUER, CHENG & ASSOCIATES, INC. 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 | 1982-10-19 |
| Decision Date | 1982-11-10 |