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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 K161101
Device Name PolypVac Microdebrider (3.3mm and 4.0mm)
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 Received04/19/2016
Decision Date 06/22/2016
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
Predetermined Change
Control Plan Authorized		 No
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