FDA 510(k) Application Details - K110646

Device Classification Name Bone Sonometer

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510(K) Number K110646
Device Name Bone Sonometer
Applicant BEAM-MED LTD
8 HALAPID STR.
PETACH TIKVA 49170 IL
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Contact RITA KOREMBLUM
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Regulation Number 892.1180

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Classification Product Code MUA
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Date Received 03/04/2011
Decision Date 10/12/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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