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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 K261614
Device Name LED LCD Monitor (OEV-271H)
Applicant
Lg Electronics.Inc
168, Suchul-Daero
Gumi-Si,  KR 39368
Applicant Contact Wonhi Lee
Correspondent
Lg Electronics.Inc
168, Suchul-Daero
Gumi-Si,  KR 39368
Correspondent Contact Wonhi Lee
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/15/2026
Decision Date 07/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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