The following data is part of a premarket notification filed by Black & Decker(tm) with the FDA for 450/800 Drill.
Device ID | K812436 |
510k Number | K812436 |
Device Name: | 450/800 DRILL |
Classification | Motor, Drill, Electric |
Applicant | BLACK & DECKER(TM) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HBC |
CFR Regulation Number | 882.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-26 |
Decision Date | 1981-11-02 |