The following data is part of a premarket notification filed by Jerome Medical with the FDA for Torquedriver Wrench.
| Device ID | K870053 |
| 510k Number | K870053 |
| Device Name: | TORQUEDRIVER WRENCH |
| Classification | Wrench |
| Applicant | JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
| Contact | Suzanne B Beacher |
| Correspondent | Suzanne B Beacher JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
| Product Code | HXC |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-07 |
| Decision Date | 1987-03-11 |