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FDA 510(k) Application Details - K122686
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K122686
Device Name
Set, Administration, Intravascular
Applicant
ROCHE DIABETES CARE AG
KIRCHBERGSTRASSE 190
BURGDORF CH-3401 CH
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Contact
CATHERINE GREEN
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2012
Decision Date
11/16/2012
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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