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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ear, Nose And Throat, Synthetic, Absorbable
510(k) Number K251790
Device Name SeptAlign
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 Number874.3620
Classification Product Code
NHB  
Date Received06/11/2025
Decision Date 01/16/2026
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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