DeviceClearance

ELECTRIC SURGICAL DRILL— 510(k) K940016

Substantially Equivalent

Alamo City Dental Supply Co.

FDA 510(k) clearance K940016 for ELECTRIC SURGICAL DRILL, Substantially Equivalent on 1994-11-22. Applicant: Alamo City Dental Supply Co.. Device class: 2.

Clearance details

Applicant
Alamo City Dental Supply Co.
Product code
Code ERL
Device class
Class 2
Regulation
21 CFR 874.4250
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Antonio, TX, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code ERL

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Adverse events under product code ERL

product code ERL
Malfunction
11,234
Total
11,234

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.