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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 K210584
Device Name SDC3 HD Information Management System with Wireless Device Control Capability
Applicant
Stryker
5900 Optical Ct
San Jose,  CA  95138
Applicant Contact Divya Sekar
Correspondent
Stryker
5900 Optical Ct
San Jose,  CA  95138
Correspondent Contact Divya Sekar
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HRX  
Date Received02/26/2021
Decision Date 03/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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