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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
Other 510(k) Applications for this Contact
Regulation Number
878.4580
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Classification Product Code
FSY
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More FDA Info for this Product Code
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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