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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Inflation, Middle Ear
510(k) Number K252751
Device Name Earflo (EF001)
Applicant
Earflo, Inc.
848 Knoll Dr.
San Carlos,  CA  94070
Applicant Contact Intan Oldakowska
Correspondent
Earflo, Inc.
584 Rio Del Mar Blvd.
Aptos,  CA  95003
Correspondent Contact Roxanne Dubois
Classification Product Code
MJV  
Date Received08/29/2025
Decision Date 02/10/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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