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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 K110218
Device Name INSPIRA AIR BALLOON DILATION SYSTEM
Applicant
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Applicant Contact KERI YEN
Correspondent
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Correspondent Contact KERI YEN
Regulation Number874.4680
Classification Product Code
KTI  
Date Received01/25/2011
Decision Date 03/31/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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