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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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More FDA Info for this Product Code
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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