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FDA 510(k) Application Details - K013620
Device Classification Name
System, X-Ray, Tomographic
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510(K) Number
K013620
Device Name
System, X-Ray, Tomographic
Applicant
MEDSTONE INTL., INC.
100 COLUMBIA, SUITE 100
ALISO VIEJO, CA 92656-4114 US
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Contact
RON BERGESON
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Regulation Number
892.1740
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Classification Product Code
IZF
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More FDA Info for this Product Code
Date Received
11/05/2001
Decision Date
01/22/2002
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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