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FDA 510(k) Application Details - K132347
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K132347
Device Name
System, Tomography, Computed, Emission
Applicant
INTER MEDICAL MEDIZINTECHNIK GMBH
14 COMMERCIAL ST, UNIT B
BRANFORD, CT 06405 US
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Contact
WILLIAM CARROLL
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
07/29/2013
Decision Date
11/20/2013
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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