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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K191102
Device Name Precision S 4K Sinuscope
Applicant
Stryker
5900 Optical Court
San Jose,  CA  95138
Applicant Contact Jessie Duong
Correspondent
Stryker
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact Jessie Duong
Regulation Number874.4760
Classification Product Code
EOB  
Date Received04/25/2019
Decision Date 09/06/2019
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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