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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 K121362
Device Name 1.5T 16CH FLEX SPEEDER LARGE
Applicant
NEOCOIL, LLC
N27 W23910A PAUL RD.
PEWAUKEE,  WI  53072
Applicant Contact STEVEN NICHOLS
Correspondent
NEOCOIL, LLC
N27 W23910A PAUL RD.
PEWAUKEE,  WI  53072
Correspondent Contact STEVEN NICHOLS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received05/07/2012
Decision Date 06/15/2012
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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