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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ent Manual Surgical
510(k) Number K201398
Device Name SINUSPRIME Dilation System
Applicant
Stryker ENT
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Applicant Contact Bruce Backlund
Correspondent
Stryker ENT
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Correspondent Contact Bruce Backlund
Regulation Number874.4420
Classification Product Code
LRC  
Subsequent Product Code
PNZ  
Date Received05/28/2020
Decision Date 10/15/2020
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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