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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 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07601
Applicant Contact GEORGE MYERS
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
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
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