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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Sonometer
510(k) Number K110646
Device Name BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER
Applicant
Beam-Med, Ltd.
8 Halapid St.
Petach Tikva,  IL 49170
Applicant Contact RITA KOREMBLUM
Correspondent
Beam-Med, Ltd.
8 Halapid St.
Petach Tikva,  IL 49170
Correspondent Contact RITA KOREMBLUM
Regulation Number892.1180
Classification Product Code
MUA  
Date Received03/04/2011
Decision Date 10/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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