FDA 510(k) Application Details - K963070

Device Classification Name Set, Administration, Intravascular

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510(K) Number K963070
Device Name Set, Administration, Intravascular
Applicant MILLER PRODUCTS AND SERVICES
4515 HWY. 47 NORTH
CHARLOTTE, TN 37036 US
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Contact CINDY MILLER
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 08/07/1996
Decision Date 09/13/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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