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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K020601
Device Name FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
Applicant
Odin Medical Technologies , Ltd.
P.O. Box 248
Yokneam Elit,  IL 20692
Applicant Contact ADI ICKOWICZ
Correspondent
Odin Medical Technologies , Ltd.
P.O. Box 248
Yokneam Elit,  IL 20692
Correspondent Contact ADI ICKOWICZ
Regulation Number892.1000
Classification Product Code
MOS  
Date Received02/22/2002
Decision Date 04/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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