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FDA 510(k) Application Details - K092471
Device Classification Name
Camera, Scintillation (Gamma)
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510(K) Number
K092471
Device Name
Camera, Scintillation (Gamma)
Applicant
GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A
CAMINO DE VERA S/N
EDIFICIO 9B
VALENCIA 46022 ES
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SEVERINE MOINE
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Regulation Number
892.1100
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Classification Product Code
IYX
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Date Received
08/11/2009
Decision Date
10/02/2009
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
Y
Expedited Review
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