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FDA 510(k) Application Details - K072983
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K072983
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
NEW MEDICAL CO., LTD.
4F, NO.42, SINGZHONG RD.
NEIHU DISTRICT
TAIPEI 114 TW
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Contact
YOUNG-HOON SHIN
Other 510(k) Applications for this Contact
Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
MQB
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More FDA Info for this Product Code
Date Received
10/23/2007
Decision Date
11/13/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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