FDA 510(k) Application Details - K090502

Device Classification Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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510(K) Number K090502
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant U.S. SAFETY SYRINGES CO., INC.
1676 VILLAGE GREEN
CROFTON, MD 21114 US
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Contact CHRISTINA SMITH
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 02/25/2009
Decision Date 03/10/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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