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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 K261544
Device Name Hydro Irrigation System
Applicant
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Applicant Contact Divya Sekar
Correspondent
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Correspondent Contact Divya Sekar
Regulation Number874.4760
Classification Product Code
EOB  
Date Received05/08/2026
Decision Date 06/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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