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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 K110610
Device Name 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
Applicant
Ge Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact MICHELLE SCHEIDT
Correspondent
Ge Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact MICHELLE SCHEIDT
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/03/2011
Decision Date 04/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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