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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 K151830
Device Name Hummingbird Tympanostomy Tube
Applicant
Preceptis Medical
505 Hwy. 169 N., #365
Plymouth,  MN  55441
Applicant Contact Keith Leland
Correspondent
Preceptis Medical
505 Hwy. 169 N., #365
Plymouth,  MN  55441
Correspondent Contact Keith Leland
Regulation Number874.3880
Classification Product Code
ETD  
Date Received07/06/2015
Decision Date 09/21/2015
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
Predetermined Change
Control Plan Authorized		 No
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