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FDA 510(k) Application Details - K002463
Device Classification Name
Light, Surgical, Ceiling Mounted
More FDA Info for this Device
510(K) Number
K002463
Device Name
Light, Surgical, Ceiling Mounted
Applicant
SKYTRON, DIV. THE KMW GROUP, INC.
5000 36TH ST S.E.
P.O.BOX 888615
GRAND RAPIDS, MI 49588-8615 US
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Contact
KARI OGREEN
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
FSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/10/2000
Decision Date
11/08/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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