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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 K013150
Device Name MR-GUIDE 2000
Applicant
Ultraguide , Ltd.
377 Route 17 S.
Hasbrouck Heights,  NJ  07601
Applicant Contact GEORGE MYERS
Correspondent
Ultraguide , Ltd.
377 Route 17 S.
Hasbrouck Heights,  NJ  07601
Correspondent Contact GEORGE MYERS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/20/2001
Decision Date 10/18/2001
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
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