FDA 510(k) Application Details - K965208

Device Classification Name Tubing, Fluid Delivery

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510(K) Number K965208
Device Name Tubing, Fluid Delivery
Applicant MEDTRONIC MINIMED
12744 SAN FERNANDO RD.
SYLMAR, CA 91342 US
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Contact TERRANCE H GREGG
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Regulation Number 880.5440

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Classification Product Code FPK
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Date Received 12/27/1996
Decision Date 02/26/1997
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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