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FDA 510(k) Application Details - K100282
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K100282
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
TERUMO CORP.
950 ELKTON BOULEVARD
ELKTON, MD 21921 US
Other 510(k) Applications for this Company
Contact
CHRISTINA FLANAGAN
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
FOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2010
Decision Date
02/26/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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