FDA 510(k) Application Details - K000263

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K000263
Device Name Pump, Infusion, Elastomeric
Applicant GO MEDICAL INDUSTRIES PTY. LTD.
200 CHURCHILL AVE.
SUBIACO, PERTH 6008 AU
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Contact GEORGE O'NEIL
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 01/28/2000
Decision Date 05/09/2000
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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