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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 K222079
Device Name Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
Applicant
Stryker Endoscopy
5900 Optical Ct
San Jose,  CA  95138
Applicant Contact Divya Sekar
Correspondent
Stryker Endoscopy
5900 Optical Ct
San Jose,  CA  95138
Correspondent Contact Divya Sekar
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HRX  
Date Received07/15/2022
Decision Date 10/11/2022
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
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