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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 K093689
Device Name 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS
Applicant
Mr Medical Solutions, LLC
310 Vista Park Dr.
Pittsburg,  PA  15205
Applicant Contact FAHAD ALRADADY
Correspondent
Mr Medical Solutions, LLC
310 Vista Park Dr.
Pittsburg,  PA  15205
Correspondent Contact FAHAD ALRADADY
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/30/2009
Decision Date 08/31/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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