FDA 510(k) Application Details - K960001

Device Classification Name Pump, Infusion, Insulin

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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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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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