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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, stationary
510(k) Number K120752
Model AERODR STITCHING SYSTEM
Device Name AERODR STITCHING SYSTEM
Original Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 east 45th st., 25th floor
two grand central tower
new york,  NY  10017
Original Contact russel munves
Regulation Number892.1680
Classification Product Code
KPR  
Date Received03/12/2012
Decision Date 06/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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