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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 K043038
Device Name BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
Applicant
Biotop Technology Co., Ltd.
12 F-2, # 130
Chung-Hsiao E.Rd.,Sec.2
Taipei,  TW 100
Applicant Contact MARK LIEN
Correspondent
Biotop Technology Co., Ltd.
12 F-2, # 130
Chung-Hsiao E.Rd.,Sec.2
Taipei,  TW 100
Correspondent Contact MARK LIEN
Regulation Number880.5860
Classification Product Code
MEG  
Date Received11/04/2004
Decision Date 12/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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