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FDA 510(k) Application Details - K960001
Device Classification Name
Pump, Infusion, Insulin
More FDA Info for this Device
510(K) Number
K960001
Device Name
Pump, Infusion, Insulin
Applicant
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR, CA 91342 US
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Contact
D ON
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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
01/02/1996
Decision Date
04/30/1996
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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