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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drill, surgical, ent (electric or pneumatic) including handpiece
510(k) Number K163247
Device Name 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
Applicant
LAURIMED LLC
500 ARGUELLO ST., SUITE 100
REDWOOD CITY,  CA  94063
Applicant Contact Brian R DuBois
Correspondent
LAURIMED LLC
500 ARGUELLO ST., SUITE 100
REDWOOD CITY,  CA  94063
Correspondent Contact Brian R DuBois
Regulation Number874.4250
Classification Product Code
ERL  
Date Received11/18/2016
Decision Date 03/09/2017
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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