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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K162648
Device Name U-Blade Veress Needle
Applicant
Tianjin Uwell Medical Device Manufacturing Co., Ltd.
A02, Plant B, # 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, # 278, Hangkong Rd., Tianjin Free Trade Zone
Tianjin,  CN 300308
Correspondent Contact TAO FAN
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
FHO  
Date Received09/22/2016
Decision Date 12/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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