DeviceClearance

OtoSet- Ear Cleaning System— 510(k) K201877

Substantially Equivalent

Safkan, Inc.

FDA 510(k) clearance K201877 for OtoSet- Ear Cleaning System, Substantially Equivalent on 2020-11-05. Applicant: Safkan, Inc..

Clearance details

Applicant
Safkan, Inc.
Product code
Code KYZ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tucson, AZ, US
Download summary PDFView on FDA.gov ↗

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