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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 K052579
Device Name PORTAL GRAVITY SYSTEM
Applicant
PORTAL, INC.
1350 NORTH 200 WEST, #6
P.O. BOX 6141
LOGAN,  UT  84341
Applicant Contact DAVID CARTER
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
JAK  
Date Received09/20/2005
Decision Date 09/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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