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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K082174
Device Name Y-ADAPTER
Applicant
ASTHMATX, INC.
888 ROSS DRIVE
SUNNYVALE,  CA  94089
Applicant Contact CARTER NAVARRO
Correspondent
ASTHMATX, INC.
888 ROSS DRIVE
SUNNYVALE,  CA  94089
Correspondent Contact CARTER NAVARRO
Regulation Number874.4680
Classification Product Code
KTI  
Date Received08/01/2008
Decision Date 10/20/2008
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
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