FDA 510(k) Application Details - K111517

Device Classification Name Injector, Fluid, Non-Electrically Powered

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510(K) Number K111517
Device Name Injector, Fluid, Non-Electrically Powered
Applicant PHARMAJET, INC.
400 CORORATE CIRCLE, SUITE N
GOLDEN, CO 80401 US
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Contact MICHAEL J RYAN
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Regulation Number 880.5430

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Classification Product Code KZE
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Date Received 06/02/2011
Decision Date 07/27/2011
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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