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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 K082916
Device Name HRB-127-32 HIGH RESOLUTION BRAIN COIL
Applicant
Invivo
3545 SW 47th Ave.
Florida,  FL  32608
Applicant Contact JEFF WILKINSON
Correspondent
Invivo
3545 SW 47th Ave.
Florida,  FL  32608
Correspondent Contact JEFF WILKINSON
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/30/2008
Decision Date 10/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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