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FDA 510(k) Application Details - K112974
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K112974
Device Name
System, Image Processing, Radiological
Applicant
CURVE DENTAL, INC.
424 W. 800 N. SUITE 202
OREM, UT 84057 US
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Contact
GEORGE STANTCHEV
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
10/05/2011
Decision Date
10/20/2011
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
Y
Expedited Review
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