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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 K050476
Device Name CORDLESS COIL
Applicant
SIEMENS MEDICAL SOLUTION, INC. USA
51 VALLEY STREAM PKWY. E50
MALVERN,  PA  19355
Applicant Contact ANA LADINO
Correspondent
SIEMENS MEDICAL SOLUTION, INC. USA
51 VALLEY STREAM PKWY. E50
MALVERN,  PA  19355
Correspondent Contact ANA LADINO
Regulation Number892.1000
Classification Product Code
MOS  
Date Received02/24/2005
Decision Date 03/25/2005
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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