The following data is part of a premarket notification filed by Black & Decker(tm) with the FDA for Sagittal Saw.
| Device ID | K812438 |
| 510k Number | K812438 |
| Device Name: | SAGITTAL SAW |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | BLACK & DECKER(TM) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-26 |
| Decision Date | 1981-11-02 |