FDA 510(k) Application Details - K122686

Device Classification Name Set, Administration, Intravascular

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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
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Regulation Number 880.5440

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Classification Product Code FPA
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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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