The following data is part of a premarket notification filed by Black & Decker(tm) with the FDA for 150 Driver/reamer.
| Device ID | K800312 |
| 510k Number | K800312 |
| Device Name: | 150 DRIVER/REAMER |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | BLACK & DECKER(TM) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-12 |
| Decision Date | 1980-02-22 |