FDA 510(k) Application Details - K123226

Device Classification Name

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510(K) Number K123226
Device Name LESSRAY
Applicant SAFERAY SPINE, LLC
13417 QUIVAS ST
WESTMINSTER, CO 80234 US
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Contact Calley Herzog
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Regulation Number

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Classification Product Code OWB
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Date Received 10/15/2012
Decision Date 12/05/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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