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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 K011418
Device Name ULTRAGUIDE MR-GUIDE 3000
Applicant
Ultraguide , Ltd.
377 Rte. 17 S.
Hasbrouck Heights,  NJ  07601
Applicant Contact GEORGE MYERS
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/09/2001
Decision Date 05/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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