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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K093738
Device Name MRI PATIENT POSITIONING DEVICES
Applicant
MEDTEC, INC.
102 first street south
kalona,  IA  52247 -9589
Applicant Contact james leong
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25th street, nw
buffalo,  MN  55313
Correspondent Contact mark job
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/04/2009
Decision Date 05/14/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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