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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 K032747
Device Name BIOTOP DJT-A SAFETY SYRINGE
Applicant
Biotop Technology Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
Biotop Technology Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number880.5860
Classification Product Code
MEG  
Date Received09/04/2003
Decision Date 05/11/2004
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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