MICROMATE 304— 510(k) K896401

Substantially Equivalent

Madsen North America, Inc.

FDA 510(k) clearance K896401 for MICROMATE 304, Substantially Equivalent on 1990-03-27. Applicant: Madsen North America, Inc..

Clearance details

Applicant
Madsen North America, Inc.
Product code
Code EWO
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Tonawanda, NY, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EWO

product code EWO
Other
2
Total
2

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.