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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
Predetermined Change
Control Plan Authorized		 No
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