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FDA 510(k) Application Details - K963273
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K963273
Device Name
System, Tomography, Computed, Emission
Applicant
SMV AMERICA
8380 DARROW RD.
TWINSBURG, OH 44087 US
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Contact
TOM BOONE
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
08/20/1996
Decision Date
03/11/1997
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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