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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 K965044
Device Name GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
Applicant
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Applicant Contact THOMAS J SPACKMAN
Correspondent
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Correspondent Contact THOMAS J SPACKMAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/13/1996
Decision Date 06/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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