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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K141349
Device Name Disposable sterile needle retractable safety syringe
Applicant
Guangdong Haiou Medical Apparatus Stock Co., Ltd.
Mazha Industrial Area, Liusha Town
Baiyun District Of Guangzhou City
Puning City,  CN 518034
Applicant Contact SALON CHEN
Correspondent
Ghtf Medical & Drug Technology Services Institutions
Tianbo Office Rm. 225, Sha Tai Rd. # 209
Baiyun District Of Guangzhou City,  CN 5100000
Correspondent Contact SALON CHEN
Regulation Number880.5860
Classification Product Code
MEG  
Date Received05/22/2014
Decision Date 04/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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