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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 K142282
FOIA Releasable 510(k) K142282
Device Name HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
Applicant
PRECEPTIS MEDICAL
505 HIGHWAY 169 NORTH, #365
plymouth,  MN  55441
Applicant Contact keith leland
Correspondent
PRECEPTIS MEDICAL
505 HIGHWAY 169 NORTH, #365
plymouth,  MN  55441
Correspondent Contact keith leland
Regulation Number874.3880
Classification Product Code
ETD  
Date Received08/15/2014
Decision Date 04/23/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT02165384
Reviewed by Third Party No
Combination Product No
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