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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 K943320
Device Name HEAD AND NECK COIL FOR THE GYREX 2T-DLX
Applicant
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Applicant Contact K. MURRAY
Correspondent
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Correspondent Contact K. MURRAY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/11/1994
Decision Date 11/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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