FDA 510(k) Application Details - K032962

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

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510(K) Number K032962
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant ARROW INTL., INC.
2400 BERNVILLE RD.
READING, PA 19605 US
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Contact ELIZABETH PRICE
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 09/23/2003
Decision Date 10/29/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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