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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 K211234
Device Name RedEx
Applicant
Advanced Surgical Concepts, Ltd.
Unit 4 Sunnybank Center, Upper Dargle Rd.
Bray,  IE A98 E339
Applicant Contact Edward Hyland
Correspondent
Hogan Lovells US LLP
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Jonathan S. Kahan
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/23/2021
Decision Date 09/17/2021
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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