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.. Device class: 1.

Clearance details

Applicant
Safkan, Inc.
Product code
Code KYZ
Device class
Class 1
Regulation
21 CFR 880.6960
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tucson, AZ, US
Download summary PDFView on FDA.gov ↗

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