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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 K150068
Device Name Unimicro Veress Needle
Applicant
Unimicro Medical Systems (Shenzhen) Co., Ltd.
2/F, Bldg. 31, The 3rd Industrial Area, Mashantou,
Gongming St., Guangming New District
Shenzhen,  CN 518106
Applicant Contact Weizhong Chen
Correspondent
Unimicro Medical Systems (Shenzhen) Co., Ltd.
2/F, Bldg. 31, The 3rd Industrial Area, Mashantou,
Gongming St., Guangming New District
Shenzhen,  CN 518106
Correspondent Contact Weizhong Chen
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
FHO  
Date Received01/13/2015
Decision Date 07/31/2015
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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