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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 K935549
Device Name GYREX 2T-SGR
Applicant
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Applicant Contact ROCHELLE M SOBEL
Correspondent
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK,  NJ  07601
Correspondent Contact ROCHELLE M SOBEL
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/17/1993
Decision Date 08/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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