FDA 510(k) Application Details - K994274

Device Classification Name Pump, Infusion

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510(K) Number K994274
Device Name Pump, Infusion
Applicant QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN, TX 75002 US
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Contact MALCOLM LEWIS
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 12/20/1999
Decision Date 05/31/2000
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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