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FDA 510(k) Application Details - K083873
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
More FDA Info for this Device
510(K) Number
K083873
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
PFM MEDICAL, INC
2605 TEMPLE HEIGHTS DRIVE
SUITE A
OCEANSIDE, CA 92056 US
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Contact
SALVADORE PALOMARES
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
12/29/2008
Decision Date
03/19/2009
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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