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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K142909
Device Name Flexible 19G EBUS Needle
Applicant
SPIRATION, INC.
6675 185TH AVENUE NE
REDMOND,  WA  98052
Applicant Contact Cyndy J Adams
Correspondent
SPIRATION, INC.
6675 185TH AVENUE NE
REDMOND,  WA  98052
Correspondent Contact Cyndy J Adams
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/06/2014
Decision Date 04/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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