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FDA 510(k) Application Details - K033001
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K033001
Device Name
System, Tomography, Computed, Emission
Applicant
TRANSPHOTON CORPORATION
37 ELECTRIC AVENUE
LUNENBURG, MA 01462 US
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Contact
SCOTT JENNINGS
Other 510(k) Applications for this Contact
Regulation Number
892.1200
More FDA Info for this Regulation Number
Classification Product Code
KPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2003
Decision Date
12/24/2003
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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