FDA 510(k) Application Details - K123776

Device Classification Name Lamp, Surgical

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510(K) Number K123776
Device Name Lamp, Surgical
Applicant DRAGER MEDICAL GMBH
6 TECH DRIVE
ANDOVER, MA 01810 US
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Contact BETH ZIS
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Regulation Number 878.4580

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Classification Product Code FTD
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Date Received 12/10/2012
Decision Date 03/08/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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