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FDA 510(k) Application Details - K082138
Device Classification Name
Injector, Fluid, Non-Electrically Powered
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510(K) Number
K082138
Device Name
Injector, Fluid, Non-Electrically Powered
Applicant
PERFACTION, INC.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
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Contact
JONATHAN S KAHAN
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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
07/29/2008
Decision Date
01/23/2009
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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