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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K926275
Device Name PHILIPS MRI BREAST COIL
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST,  NL
Applicant Contact WILLIAM G MCMAHON
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST,  NL
Correspondent Contact WILLIAM G MCMAHON
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/14/1992
Decision Date 10/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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