The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Dosimetric Release Of Gamma Radiation.
| Device ID | K832211 |
| 510k Number | K832211 |
| Device Name: | DOSIMETRIC RELEASE OF GAMMA RADIATION |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | KIRSCHNER MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-06 |
| Decision Date | 1983-09-29 |