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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coil, magnetic resonance, specialty
510(k) Number K130706
Device Name DUOFLEX COIL SUITE (1.5T)
Applicant
MR INSTRUMENTS, INC.
5610 ROWLAND RD.
SUITE 145
MINNEAPOLIS,  MN  54343
Applicant Contact ROBERT BECK
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/15/2013
Decision Date 07/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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