FDA 510(k) Application Details - K991203

Device Classification Name Pump, Infusion

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510(K) Number K991203
Device Name Pump, Infusion
Applicant KMI KOLSTER METHODS, INC.
2550 WEST ROWLAND AVE.
ANAHEIM, CA 92804 US
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Contact ALWIN H KOLSTER
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 04/08/1999
Decision Date 10/15/1999
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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