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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 K022157
Device Name RF TENT
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 Received07/02/2002
Decision Date 08/28/2002
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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