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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
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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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