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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 K090660
Device Name AIRWAY BALLOON CATHETER INFLATION DEVICE
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 Received03/12/2009
Decision Date 06/12/2009
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
Recalls CDRH Recalls
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