FDA 510(k) Application Details - K990259

Device Classification Name Pump, Infusion

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510(K) Number K990259
Device Name Pump, Infusion
Applicant DISETRONIC MEDICAL SYSTEMS
7690 CAMERON CIRCLE
FT. MEYERS, FL 33912 US
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Contact Lee Leichter
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 01/27/1999
Decision Date 02/12/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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