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FDA 510(k) Application Details - K050760
Device Classification Name
Pump, Infusion, Insulin
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510(K) Number
K050760
Device Name
Pump, Infusion, Insulin
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
Scott Thiel
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Regulation Number
880.5725
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Classification Product Code
LZG
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More FDA Info for this Product Code
Date Received
03/24/2005
Decision Date
09/13/2005
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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