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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 K210088
Device Name 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
Applicant
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact Jessie Duong
Correspondent
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact Jessie Duong
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
FCS   FCW   OWN  
Date Received01/13/2021
Decision Date 04/13/2021
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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