FDA 510(k) Application Details - K024018

Device Classification Name Injector, Fluid, Non-Electrically Powered

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510(K) Number K024018
Device Name Injector, Fluid, Non-Electrically Powered
Applicant AVANT MEDICAL CORPORATION
3914 KENDALL ST.
SAN DIEGO, CA 92109 US
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Contact JOHN B SLATE
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Regulation Number 880.5430

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Classification Product Code KZE
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Date Received 12/04/2002
Decision Date 01/17/2003
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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