FDA 510(k) Application Details - K024249

Device Classification Name Syringe, Antistick

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510(K) Number K024249
Device Name Syringe, Antistick
Applicant TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON, MD 21921 US
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Contact BARBARA SMITH
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 12/23/2002
Decision Date 02/21/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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