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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 K202303
Device Name CORE E3 Suction/irrigator
Applicant
ConMed Corporation
525 French Road
Utica,  NY  13502
Applicant Contact Tina Mornak
Correspondent
ConMed Corporation
525 French Road
Utica,  NY  13502
Correspondent Contact Tina Mornak
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/14/2020
Decision Date 02/19/2021
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
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