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FDA 510(k) Application Details - K012641
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
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510(K) Number
K012641
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
FAS MEDICAL LTD.
PO BOX 219
INDIAN HILLS, CO US
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Contact
THOMAS KROENKE
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Regulation Number
880.5970
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Classification Product Code
LJS
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More FDA Info for this Product Code
Date Received
08/13/2001
Decision Date
10/15/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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