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FDA 510(k) Application Details - K970970
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K970970
Device Name
System, Tomography, Computed, Emission
Applicant
FOCUS MEDICAL SA
70 WALNUT ST.
WELLESLEY, MA 02181 US
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Contact
JEAN-LUC BOULNOIS
Other 510(k) Applications for this Contact
Regulation Number
892.1200
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Classification Product Code
KPS
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More FDA Info for this Product Code
Date Received
03/17/1997
Decision Date
06/13/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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