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FDA 510(k) Application Details - K053345
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
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510(K) Number
K053345
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
MEDCOMP
1499 DELP DR.
HARLEYSVILLE, PA 19438 US
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Contact
JEAN CALLOW
Other 510(k) Applications for this Contact
Regulation Number
880.5970
More FDA Info for this Regulation Number
Classification Product Code
LJS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/02/2005
Decision Date
03/17/2006
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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