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FDA 510(k) Application Details - K991473
Device Classification Name
Reader, Zone, Automated
More FDA Info for this Device
510(K) Number
K991473
Device Name
Reader, Zone, Automated
Applicant
INTELLIGENCE ARTIFICIELLE APPLICATIONS
1301 K ST. N.W.
SUITE 1100- EAST TOWER
WASHINGTON, DC 20005 US
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Contact
MARC J SCHEINESON
Other 510(k) Applications for this Contact
Regulation Number
866.2850
More FDA Info for this Regulation Number
Classification Product Code
KZK
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More FDA Info for this Product Code
Date Received
04/27/1999
Decision Date
11/23/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K991473
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