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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 K062780
Device Name CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE
Applicant
Medical Device Manufacturer (Thailand) , Ltd.
7/145 Moo 4
Amata City Industrial Estate
Rayong,  TH 21140
Applicant Contact OYTIP KUNWUNLOP
Correspondent
Medical Device Manufacturer (Thailand) , Ltd.
7/145 Moo 4
Amata City Industrial Estate
Rayong,  TH 21140
Correspondent Contact OYTIP KUNWUNLOP
Regulation Number880.5860
Classification Product Code
MEG  
Date Received09/18/2006
Decision Date 01/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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