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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 K233327
Device Name 1788 4K Camera System with Advanced Imaging Modality
Applicant
Stryker Endoscopy
5900 Optical Court
San Jose,  CA  95138
Applicant Contact Mrs. Michelle Stephens
Correspondent
Stryker Endoscopy
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact Mrs. Michelle Stephens
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/29/2023
Decision Date 01/09/2024
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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