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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 K162387
Device Name U-IGNITE Bladeless Trocar
Applicant
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD.
A02, PLANT B, NO. 278, HANGKONG RD, TIANJIN FREE TRADE ZONE
TIANJIN,  CN 300308
Applicant Contact TAO FAN
Correspondent
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD.
A02, PLANT B, NO. 278, HANGKONG RD, TIANJIN FREE TRADE ZONE
TIANJIN,  CN 300308
Correspondent Contact TAO FAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/25/2016
Decision Date 01/11/2017
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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