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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K201877
Device Name OtoSet- Ear Cleaning System
Applicant
Safkan, Inc.
1665 E 18th St. #205
Tucson,  AZ  85719
Applicant Contact Sahil Diwan
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number880.6960
Classification Product Code
KYZ  
Subsequent Product Code
LRD  
Date Received07/07/2020
Decision Date 11/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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