450/800 DRILL— 510(k) K812436

Substantially Equivalent

Black & Decker(Tm)

FDA 510(k) clearance K812436 for 450/800 DRILL, Substantially Equivalent on 1981-11-02. Applicant: Black & Decker(Tm).

Clearance details

Applicant
Black & Decker(Tm)
Product code
Code HBC
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HBC

product code HBC
Malfunction
4,715
Total
4,715

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.