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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 K201593
Device Name Looking Glass 4K Integrated Visualization System
Applicant
ConMed Corporation
525 French Road
Utica,  NY  13502
Applicant Contact Kavita Amin
Correspondent
ConMed Corporation
525 French Road
Utica,  NY  13502
Correspondent Contact Kavita Amin
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/12/2020
Decision Date 07/08/2020
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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