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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K260270
Device Name FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
Applicant
FindAir Sp. z o.o.
Glogowa 26
Kraków,  PL 31-235
Applicant Contact Anna Pawlik
Correspondent
Pure Global
11 Town Sq. Pl., Suite 1203
Jersey City,  NJ  07310
Correspondent Contact Oliver Eikenberg
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/28/2026
Decision Date 06/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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