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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 K050237
Device Name STARSHIELD V3 RF TRNT
Applicant
Odin Medical Technologies , Ltd.
P.O Box 548
Yokneam Elit,  IL 20692
Applicant Contact ADI ICKOWICZ
Correspondent
Odin Medical Technologies , Ltd.
P.O Box 548
Yokneam Elit,  IL 20692
Correspondent Contact ADI ICKOWICZ
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/02/2005
Decision Date 03/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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