FDA 510(k) Application Details - K952967

Device Classification Name Pump, Infusion

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510(K) Number K952967
Device Name Pump, Infusion
Applicant A.Z.E. MEDICAL, INC.
1247 FLORIDA AVE.
PALM HAROBOR, FL 34683 US
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Contact PATRICK J LAMB
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 06/27/1995
Decision Date 02/09/1996
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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