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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Intranasal Septal
510(k) Number K243655
Device Name TurbAlign
Applicant
Spirair, Inc.
415 Grand Ave.
Suite 201
South San Francisco,  Ca  94080
Applicant Contact Tracey Henry
Correspondent
Spirair, Inc.
415 Grand Ave.
Suite 201
South San Francisco,  Ca  94080
Correspondent Contact Tracey Henry
Regulation Number874.4780
Classification Product Code
LYA  
Date Received11/26/2024
Decision Date 07/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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