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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 K143497
Device Name Safety Auto-Disable Syrine with Needle (Auto-Lock)
Applicant
Guangdong Intmed Medical Appliance Co., Ltd.
1# S. Rd. Europe Industry Park, Shunde District
Foshan,  CN 528300
Applicant Contact HU YIHAN
Correspondent
Guangdong Intmed Medical Appliance Co., Ltd.
1# S. Rd. Europe Industry Park, Shunde District
Foshan,  CN 528300
Correspondent Contact WANG SANFEI
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Codes
FMF   FMI  
Date Received12/09/2014
Decision Date 11/04/2015
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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