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 |