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FDA 510(k) Application Details - K031909
Device Classification Name
Syringe, Antistick
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510(K) Number
K031909
Device Name
Syringe, Antistick
Applicant
BETEC MEDICAL SCIENCE CO., LTD.
3892 SOUTH AMERICA WEST TRAIL
FLAGGSTAFF, AZ 86001 US
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Contact
JENNIFER REICH
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Regulation Number
880.5860
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Classification Product Code
MEG
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More FDA Info for this Product Code
Date Received
06/20/2003
Decision Date
10/07/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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