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FDA 510(k) Application Details - K042557
Device Classification Name
Introducer, Syringe Needle
More FDA Info for this Device
510(K) Number
K042557
Device Name
Introducer, Syringe Needle
Applicant
INNOJECT, INC
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004-5600 US
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Contact
JONATHAN S KAHAN
Other 510(k) Applications for this Contact
Regulation Number
880.6920
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Classification Product Code
KZH
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More FDA Info for this Product Code
Date Received
09/20/2004
Decision Date
11/08/2004
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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