The following data is part of a premarket notification filed by Jerome Medical with the FDA for System Iii Halo Ring.
| Device ID | K930153 |
| 510k Number | K930153 |
| Device Name: | SYSTEM III HALO RING |
| Classification | Component, Traction, Invasive |
| Applicant | JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
| Contact | Daniel L Clemens |
| Correspondent | Daniel L Clemens JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-12 |
| Decision Date | 1993-08-06 |