FDA 510(k) Application Details - K991363

Device Classification Name Pump, Infusion

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510(K) Number K991363
Device Name Pump, Infusion
Applicant SORENSON MEDICAL, INC.
1375 WEST 8040 SOUTH
WEST JORDAN, UT 84088-8320 US
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Contact R. DOUGLAS JACOB
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 04/20/1999
Decision Date 05/13/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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