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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 K232701
Device Name Guardenia (GAR-1)
Applicant
Advanced Surgical Concepts
Unit 4, Sunnybank Center
Upper Dargle Road
Bray,  IE A98 E339
Applicant Contact Edward Hyland
Correspondent
Advanced Surgical Concepts
Unit 4, Sunnybank Center
Upper Dargle Road
Bray,  IE A98 E339
Correspondent Contact Edward Hyland
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/05/2023
Decision Date 09/29/2023
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
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