FDA 510(k) Application Details - K052431

Device Classification Name Tubing, Fluid Delivery

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510(K) Number K052431
Device Name Tubing, Fluid Delivery
Applicant MEDTRONIC MINIMED
18000 DEVONSHIRE ST.
NORTHRIDGE, CA 91325-1219 US
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Contact JODIE ROGERS
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Regulation Number 880.5440

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Classification Product Code FPK
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Date Received 09/06/2005
Decision Date 11/29/2005
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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