FDA 510(k) Application Details - K130513

Device Classification Name Lamp, Surgical

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510(K) Number K130513
Device Name Lamp, Surgical
Applicant MAQUET SAS
45 BARBOUR POND DRIVE
WAYNE, NJ 07470 US
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Contact TOSIN YEDESS
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Regulation Number 878.4580

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Classification Product Code FTD
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Date Received 02/27/2013
Decision Date 05/08/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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