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FDA 510(k) Application Details - K090378
Device Classification Name
Light, Surgical, Ceiling Mounted
More FDA Info for this Device
510(K) Number
K090378
Device Name
Light, Surgical, Ceiling Mounted
Applicant
BERCHTOLD GMBH & CO. KG
1950 HANAHAN ROAD
CHARLESTON, SC 29406 US
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Contact
HEATH HINES
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
02/17/2009
Decision Date
02/23/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
FDA Source Information for K090378
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