The following data is part of a premarket notification filed by Black & Decker(tm) with the FDA for Cast Cutter/cast Saw/instrument.
| Device ID | K820351 |
| 510k Number | K820351 |
| Device Name: | CAST CUTTER/CAST SAW/INSTRUMENT |
| Classification | Instrument, Cast Removal, Ac-powered |
| Applicant | BLACK & DECKER(TM) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LGH |
| CFR Regulation Number | 888.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-08 |
| Decision Date | 1982-03-02 |