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FDA 510(k) Application Details - K993012
Device Classification Name
Pump, Infusion, Insulin
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510(K) Number
K993012
Device Name
Pump, Infusion, Insulin
Applicant
MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR, CA 91342 US
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Contact
JENNIFER LYONS
Other 510(k) Applications for this Contact
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
09/08/1999
Decision Date
11/15/1999
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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