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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reader, Zone, Automated
510(k) Number K991473
Device Name SIRSCAN
Applicant
Intelligence Artificielle Applications
1301 K St. NW
Suite 1100- E. Tower
Washington,  DC  20005
Applicant Contact MARC J SCHEINESON
Correspondent
Intelligence Artificielle Applications
1301 K St. NW
Suite 1100- E. Tower
Washington,  DC  20005
Correspondent Contact MARC J SCHEINESON
Regulation Number866.2850
Classification Product Code
KZK  
Date Received04/27/1999
Decision Date 11/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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