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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holding Chambers, Direct Patient Interface
510(k) Number K210558
Device Name LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
Applicant
Thayer Medical Corporation
4575 S Palo Verde Rd., Suite 337
Tucson,  AZ  85714
Applicant Contact Christine Woeppel
Correspondent
Thayer Medical Corporation
4575 S Palo Verde Rd., Suite 337
Tucson,  AZ  85714
Correspondent Contact Christine Woeppel
Regulation Number868.5630
Classification Product Code
NVP  
Date Received02/25/2021
Decision Date 04/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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