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FDA 510(k) Application Details - K153056
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K153056
Device Name
System, Tomography, Computed, Emission
Applicant
HERMES MEDICAL SOLUTIONS, AB
SKEPPSBRON 44
STOCKHOLM 11130 SE
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Contact
JOAKIM ARWIDSON
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
10/21/2015
Decision Date
06/01/2016
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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