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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 K111340
Device Name HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM
Applicant
MEDTEC, INC.
1401 8TH STREET SE
ORANGE CITY,  IA  51041
Applicant Contact JENNY JONES
Correspondent
MEDTEC, INC.
1401 8TH STREET SE
ORANGE CITY,  IA  51041
Correspondent Contact JENNY JONES
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
IYE  
Date Received05/12/2011
Decision Date 06/28/2011
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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