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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tube, Tympanostomy
510(k) Number K171239
FOIA Releasable 510(k) K171239
Device Name TULA Tube Delivery System
Applicant
Tusker Medical
155 Jefferson Drive Suite 200
Menlo Park,  CA  94025
Applicant Contact Pavan Sethi
Correspondent
Tusker Medical
155 Jefferson Drive Suite 200
Menlo Park,  CA  94025
Correspondent Contact Pavan Sethi
Regulation Number874.3880
Classification Product Code
ETD  
Date Received04/27/2017
Decision Date 06/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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