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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 K013894
Device Name TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
Applicant
Philips Medical Systems North America, Inc.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Applicant Contact LYNN HARMER
Correspondent
Philips Medical Systems North America, Inc.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Correspondent Contact LYNN HARMER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/23/2001
Decision Date 01/18/2002
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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