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FDA 510(k) Application Details - K102259
Device Classification Name
System, X-Ray, Tomography, Computed
More FDA Info for this Device
510(K) Number
K102259
Device Name
System, X-Ray, Tomography, Computed
Applicant
VATECH CO., LTD.
333 MEADOWLANDS PARKWAY,
#303
SECAUCUS, NJ 07094 US
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Contact
DAVE KIM
Other 510(k) Applications for this Contact
Regulation Number
892.1750
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Classification Product Code
JAK
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More FDA Info for this Product Code
Date Received
08/10/2010
Decision Date
02/18/2011
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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