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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 K031909
Device Name BETEC RETRACTABLE SAFETY SYRINGE (5ML)
Applicant
Betec Medical Science Co., Ltd.
3892 S. America W. Trail
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Betec Medical Science Co., Ltd.
3892 S. America W. Trail
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number880.5860
Classification Product Code
MEG  
Date Received06/20/2003
Decision Date 10/07/2003
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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