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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 K231066
Device Name CuratOR EX3242-FD
Applicant
Eizo Corporation
153 Shimokashiwano
Hakusan,  JP 924-8566
Applicant Contact Hiroaki Hashimoto
Correspondent
Eizo Corporation
153 Shimokashiwano
Hakusan,  JP 924-8566
Correspondent Contact Hiroaki Hashimoto
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/14/2023
Decision Date 12/18/2023
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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