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FDA 510(k)

OtoSet- Ear Cleaning System

K-Number: K201877 · 2020-11-05

ApplicantSafkan, Inc.
Decision Date2020-11-05
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OtoSet- Ear Cleaning System is a medical device manufactured by Safkan, Inc.. It received FDA 510(k) clearance on 2020-11-05 under approval number K201877. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OtoSet- Ear Cleaning System?

OtoSet- Ear Cleaning System is a medical device that received FDA 510(k) clearance on 2020-11-05. It is manufactured by Safkan, Inc.. The 510(k) number is K201877.

When was OtoSet- Ear Cleaning System approved by the FDA?

OtoSet- Ear Cleaning System received FDA 510(k) clearance on 2020-11-05, under approval number K201877.

What company makes OtoSet- Ear Cleaning System?

OtoSet- Ear Cleaning System is manufactured by Safkan, Inc..

What is the FDA product code for OtoSet- Ear Cleaning System?

The FDA product code for OtoSet- Ear Cleaning System is KYZ.

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Official Source

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