FDA 510(k) Application Details - K070442

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K070442
Device Name Light, Surgical, Ceiling Mounted
Applicant MAQUET S.A.
1777 EAST HENRIETTA RD.
ROCHESTER, NY 14623 US
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Contact KEVIN M TOMPKINS
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 02/15/2007
Decision Date 03/16/2007
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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