FDA 510(k) Application Details - K121444

Device Classification Name

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510(K) Number K121444
Device Name FLAT PANEL DETECTOR
Applicant CANON, INC. - MEDICAL EQUPMENT GROUP
1201 RICHARDSON DR, STE 280
RICHARDSON, TX 75080 US
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Contact DIANE RUTHERFORD
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Regulation Number

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Classification Product Code OWB
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Date Received 05/15/2012
Decision Date 06/07/2012
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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