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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K212055
Device Name Connected OR Hub with Device and Voice Control
Applicant
Stryker Corporation
5900 Optical Ct
San Jose,  CA  95138
Applicant Contact Eugene Perelshteyn
Correspondent
Stryker Corporation
5900 Optical Ct
San Jose,  CA  95138
Correspondent Contact Eugene Perelshteyn
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HRX  
Date Received07/01/2021
Decision Date 12/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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