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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 K152922
Device Name ViziShot FLEX
Applicant
Spiration, Inc.
6675 185th Ave. NE
Redmond,  WA  98052
Applicant Contact Cyndy J Adams
Correspondent
Spiration, Inc.
6675 185th Ave. NE
Redmond,  WA  98052
Correspondent Contact Cyndy J Adams
Regulation Number874.4680
Classification Product Code
KTI  
Date Received10/02/2015
Decision Date 02/19/2016
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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