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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 K220108
Device Name SDC4K Information Management System with Device and Voice Control Package
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 Received01/13/2022
Decision Date 02/09/2022
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
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