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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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More FDA Info for this Product Code
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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