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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 K150951
Device Name aeris Balloon Dialation Catheter
Bryan Medical , Inc.
3906 Oak St.
Cincinnati,  OH  45227
Applicant Contact ANDY BLACK
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number874.4680
Classification Product Code
Date Received04/09/2015
Decision Date 06/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls