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FDA 510(k) Application Details - K973044
Device Classification Name
Pump, Infusion, Insulin
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510(K) Number
K973044
Device Name
Pump, Infusion, Insulin
Applicant
DISETRONIC MEDICAL SYSTEMS
5201 EAST RIVER RD.
SUITE 312
MINNEAPOLIS, MN 55421-1014 US
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Contact
JIM MYERS
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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
08/15/1997
Decision Date
09/15/1997
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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