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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 K170899
Device Name 27HJ713S
Applicant
Lg Electronics
222, Lg-Ro, Cheongho-Ri, Jinwi-Myeon
Pyeongtaek-Si,  KR 17709
Applicant Contact Jinhwan Jun
Correspondent
Lg Electronics
222, Lg-Ro, Cheongho-Ri, Jinwi-Myeon
Pyeongtaek-Si,  KR 17709
Correspondent Contact Jinhwan Jun
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/27/2017
Decision Date 05/30/2017
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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