The following data is part of a premarket notification filed by Black & Decker(tm) with the FDA for 450 Drill/800 Drill.
Device ID | K800311 |
510k Number | K800311 |
Device Name: | 450 DRILL/800 DRILL |
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 |