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FDA 510(k) Application Details - K030690
Device Classification Name
Camera, Multi Format, Radiological
More FDA Info for this Device
510(K) Number
K030690
Device Name
Camera, Multi Format, Radiological
Applicant
CODONICS, INC.
17991 ENGLEWOOD DR.
MIDDLEBURG HEIGHTS, OH 44130 US
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Contact
RICK DAYTON
Other 510(k) Applications for this Contact
Regulation Number
892.2040
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Classification Product Code
LMC
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More FDA Info for this Product Code
Date Received
03/05/2003
Decision Date
04/30/2003
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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