FDA 510(k) Application Details - K022831

Device Classification Name Pump, Infusion, Insulin

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510(K) Number K022831
Device Name Pump, Infusion, Insulin
Applicant DISETRONIC MEDICAL SYSTEMS AG
KIRCHBERSTRASSE 190, POSTFACH
BURGDORF CH-3401 SE
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Contact SANDRA SONIEC
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Regulation Number 880.5725

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Classification Product Code LZG
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Date Received 08/26/2002
Decision Date 09/11/2002
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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