FDA 510(k) Application Details - K052389

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

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510(K) Number K052389
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant PATTON MEDICAL DEVICES
PO BOX 1490
EAGLE, ID 83616 US
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Contact FRED SCHLADOR
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 08/31/2005
Decision Date 09/09/2005
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 Y
Expedited Review



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