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FDA 510(k) Application Details - K033637
Device Classification Name
Digitizer, Image, Radiological
More FDA Info for this Device
510(K) Number
K033637
Device Name
Digitizer, Image, Radiological
Applicant
ARRAY CORP.
3-42-10 YOYOGI
SHIBUYA-KU, TOKYO 151-0053 JP
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Contact
TAKASHI INAMI
Other 510(k) Applications for this Contact
Regulation Number
892.2030
More FDA Info for this Regulation Number
Classification Product Code
LMA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2003
Decision Date
12/17/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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