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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Biopsy, Bronchoscope (Non-Rigid)
510(k) Number K130357
FOIA Releasable 510(k) K130357
Device Name SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
Applicant
Covidien, LLC
161 Cheshire Ln., Suite 100
Plymouth,  MN  55441
Applicant Contact KRISTEN SWANSON
Correspondent
Covidien, LLC
161 Cheshire Ln., Suite 100
Plymouth,  MN  55441
Correspondent Contact KRISTEN SWANSON
Regulation Number874.4680
Classification Product Code
BTG  
Date Received02/13/2013
Decision Date 11/06/2013
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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