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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 K160109
Device Name Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
Applicant
Thayer Medical Corporation
4575 S Palo Verde Rd., Suite 337
Tucson,  AZ  85714
Applicant Contact MEGHAN MCGOVERN
Correspondent
Thayer Medical Corporation
4575 S Palo Verde Rd., Suite 337
Tucson,  AZ  85714
Correspondent Contact JENNIFER LH JOHNSON
Regulation Number868.5630
Classification Product Code
NVP  
Date Received01/19/2016
Decision Date 05/19/2017
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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