OtoSet- Ear Cleaning System

Syringe, Irrigating (non Dental)

SafKan, Inc.

The following data is part of a premarket notification filed by Safkan, Inc. with the FDA for Otoset- Ear Cleaning System.

Pre-market Notification Details

Device IDK201877
510k NumberK201877
Device Name:OtoSet- Ear Cleaning System
ClassificationSyringe, Irrigating (non Dental)
Applicant SafKan, Inc. 1665 E 18th Street #205 Tucson,  AZ  85719
ContactSahil Diwan
CorrespondentAllison Komiyama
Acknowledge Regulatory Strategies, LLC 2251 San Diego Avenue Ste B-257 San Diego,  CA  92110
Product CodeKYZ  
CFR Regulation Number880.6960 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-07
Decision Date2020-11-05

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