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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K082138
Device Name AIRGENT, MODEL AG7000010
Applicant
PERFACTION, INC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
PERFACTION, INC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number880.5430
Classification Product Code
KZE  
Date Received07/29/2008
Decision Date 01/23/2009
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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