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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 K032541
Device Name POLESTAR N-20
Applicant
ODIN MEDICAL TECHNOLOGIES LTD.
P.O BOX 548
YOKNEAM ELIT,  IL 20692
Applicant Contact EINAV SHLOMOVITZ
Correspondent
ODIN MEDICAL TECHNOLOGIES LTD.
P.O BOX 548
YOKNEAM ELIT,  IL 20692
Correspondent Contact EINAV SHLOMOVITZ
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/18/2003
Decision Date 09/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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