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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, syringe needle
510(k) Number K042557
Device Name INNOJECT AUTO-INJECTOR
Applicant
INNOJECT, INC
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -5600
Applicant Contact JONATHAN S KAHAN
Correspondent
INNOJECT, INC
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -5600
Correspondent Contact JONATHAN S KAHAN
Regulation Number880.6920
Classification Product Code
KZH  
Date Received09/20/2004
Decision Date 11/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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