FDA 510(k) Application Details - K961474

Device Classification Name Set, Administration, Intravascular

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510(K) Number K961474
Device Name Set, Administration, Intravascular
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 FPA
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Date Received 04/18/1996
Decision Date 05/06/1996
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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