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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 K980306
Device Name GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
Applicant
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Applicant Contact STEVEN M KAY
Correspondent
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Correspondent Contact STEVEN M KAY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/27/1998
Decision Date 04/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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