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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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More FDA Info for this Product Code
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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