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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cradle, patient, radiologic
510(k) Number K122174
Model 5432778
Device Name PEDIATRIC POSITIONER PAD SET
Original Applicant
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
1515 danner dr
aurora,  OH  44202 9273
Original Contact michelle huettner
Regulation Number892.1830
Classification Product Code
KXH  
Date Received07/23/2012
Decision Date 11/16/2012
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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