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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 K181258
Device Name ConnectedOR Hub with Device and Voice Control
Applicant
Stryker
5900 Optical Court
San Jose,  CA  95138
Applicant Contact April Malmborg
Correspondent
Stryker
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact April Malmborg
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HRX  
Date Received05/11/2018
Decision Date 11/05/2018
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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