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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 K040105
Device Name YUE PFONG SAFETY SYRINGE (3ML)
Applicant
Yue Pfong International Industrial Co., Ltd.
3892 S. America W. Trl.
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Yue Pfong International Industrial Co., Ltd.
3892 S. America W. Trl.
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/20/2004
Decision Date 04/07/2004
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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